Reaction profile

The FDA adverse-event record for product defect, product difficult to use/handle (see also 'drug device difficult to use/handle')

Name: Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') - FDA Animal Adverse Reaction
Creator: PlainBreed
License: https://open.fda.gov/license/

1,919 FDA reports name product defect, product difficult to use/handle (see also 'drug device difficult to use/handle'), a high-volume reaction in the CVM extract (VeDDRA 99955). Plate stamps and neighbourhood peers follow.

#243 of 2,481
by report volume (all reactions): 1,919
reports citing this reaction: 0.4%
death-coded share: Unknown
most-affected species

Compiled by PlainBreed

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Release-over-release change

What changed in the latest FDA data snapshot

PlainBreed reconstructed the prior snapshot from dated openFDA partitions through 2025 Q4, then compared it with the 2026-07-27 openFDA export. Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') has 1,919 reports now versus 1,762 in that prior snapshot: 157 more (8.9%).

Report change: +157
Death-coded reports: +1
Death-coded share: +0.0 pts

This compares reported-event counts in two source snapshots. It does not establish a change in real-world risk, product safety, or disease incidence.

Subscribe to Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') changes

FDA AER · VeDDRA plate

Code 99955 VOL-MID

VOL-MID · DEATH-RARE · TOP-DECILE · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL

VOL-MID 1,919 reports
DEATH-RARE 0.4%
TOP-DECILE #243/2481
PHOTO-FINISH Application site irri…
SPECIES-UNKNOWN Unknown · 1,697
DRUG-LEAD Mirtazapine · 253
DESK-WIDE 20 breeds
BOOK-FULL 8/8 fields

Nearest volume peer: Application site irritation (±1 reports)

Upper-third report volume drives the scale stamps on this plate; death-coded share and co-report peers follow. Not a clinical diagnosis.

High-volume neighbourhood around Product defect, product difficult to use/handle

Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.

FDA AER report volume · neighbourhood around Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')

Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle'): low death-coded share in the FDA AER plate

Signature read: Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')'s 0.4% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 1,919 named reports in the openFDA extract. Death-coded share is lower-third: 7 of 1,919 reports (0.4% of named reports). Nearest volume peer: Application site irritation (±1 reports). Lead species Unknown (1,697). Lead co-reported drug Mirtazapine (253).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Mirtazapine appears in filings alongside this reaction; that is association, not causation. Browse the full reactions index or the about page for how PlainBreed frames FDA CVM extracts.

Species Most Affected

Unknown 1,697

Dog 102

Cat 82

Human 34

Horse 1

Donkey 1

Llama 1

Marsupial 1

Breeds Most Affected

Unknown 1,733

Domestic Shorthair 44

Dog (unknown) 20

Cat (unknown) 16

Domestic Longhair 6

Retriever - Labrador 5

Retriever - Golden 5

Boxer (German Boxer) 5

Chihuahua 4

Maine Coon 4

Associated Drugs

Mirtazapine 253

Cyclosporine 219

Pyrantel Pamoate;Sarolaner 219

Gentamicin Sulfate + Hydrocortisone Aceponate + Miconazole Nitrate 163

Metronidazole 118

Fluralaner Spot-On Solution 79

Lotilaner,Moxidectin,Praziquantel,Pyrantel Pamoate 58

Moxidectin 47

Velagliflozin Proline Monohydrate 46

Lotilaner 42

Fluralaner/Moxidectin Spot-On 41

Praziquantel 40

Deslorelin Acetate 34

Bexagliflozin 34

Milbemycin Oxime + Praziquantel 29

Ciclesonide 26

Meloxicam 25

Milbemycin Oxime + Spinosad 24

Oclacitinib Maleate 24

Selamectin;Sarolaner 22

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle'), both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar report volume

Nearest other reactions by FDA report count (1,919 here).

Application site irritation 1,918 Product label issues 1,916 Facial oedema 1,927 Elevated renal parameters 1,945

Similar death-coded share

Nearest other reactions by death-coded share (0.4% here), distinct from the volume row.

Lack of efficacy (ectoparasite) - NOS 0.4% Lack of efficacy (ectoparasite) - ear mite 0.4% Lot # and /or Expiration date missing 0.4% INEFFECTIVE, ASCARIDS 0.3%

What to do with this reaction

Compare Product defect, product difficult to use/handle's report profile against similar reactions nationwide. See similar reactions
Read how death-coded share differs from a mortality rate before drawing conclusions. Understanding adverse events
Browse the full reaction directory to compare report counts across reaction types. All reactions

A report does not prove a drug caused the reaction; consult a veterinarian before acting on this data.

Source: FDA Center for Veterinary Medicine openFDA Animal & Veterinary Adverse Events (CVM AER) · 2025

openFDA Animal & Veterinary Adverse Events (FDA CVM) for Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle') (#243 of 2,481 by report volume); death-coded 0.4%. PlainBreed reaction plate · death-coded share stamp 0.4% · vintage 2025.

Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →