Reaction profile

The FDA adverse-event record for product defect nos

406 FDA reports name product defect nos, a high-volume reaction in the CVM extract (VeDDRA 2283). Plate stamps and neighbourhood peers follow.

#719 of 2,481
by report volume (all reactions)
406
reports citing this reaction
2.0%
death-coded share
Unknown
most-affected species

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 NOS has 406 reports now versus 358 in that prior snapshot: 48 more (13.4%).

Report change
+48
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 NOS changes

FDA AER · VeDDRA plate

Code 2283 VOL-LOW

VOL-LOW · DEATH-LOW · MID-PACK · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL

  • VOL-LOW 406 reports
  • DEATH-LOW 2.0%
  • MID-PACK #719/2481
  • PHOTO-FINISH Injection site scab
  • SPECIES-UNKNOWN Unknown · 305
  • DRUG-LEAD Oclacitinib Malea… · 60
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Injection site scab (±0 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 NOS

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

Vomiting · highest174348Injection site erythe… · near407Injection site scab · near406Product defect NOS · this re…406Loss of vision · near405Oral ulceration · near405Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Product defect NOS

Product defect NOS: low death-coded share in the FDA AER plate

Signature read: Product defect NOS's 2.0% death-coded share is among the lowest in the openFDA reaction corpus. Report volume is upper-third scale: 406 named reports in the openFDA extract. Death-coded share is lower-third: 8 of 406 reports (2.0% of named reports). Nearest volume peer: Injection site scab (±0 reports). Lead species Unknown (305). Lead co-reported drug Oclacitinib Maleate (60).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Oclacitinib Maleate 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 305
Dog 58
Cat 25
Human 16
Other 1
Horse 1

Breeds Most Affected

Unknown 322
Domestic Shorthair 14
Cat (unknown) 8
Dog (unknown) 7
Retriever - Golden 5
Chihuahua 4
Pit Bull 4
Spitz - German Pomeranian 3
Terrier - Bull - American Pit 3
Crossbred Canine/dog 2

Associated Drugs

Oclacitinib Maleate 60
Water, Sodium Chloride, Sodium Lactate, Potassium Chloride, Calcium Chloride 33
Lotilaner,Moxidectin,Praziquantel,Pyrantel Pamoate 30
Bedinvetmab 25
Metronidazole 22
Amoxicillin (As Trihydrate) + Clavulanic Acid (As Potassium Clavulanate) 16
Levamisole Hydrochloride;Doramectin 15
Praziquantel 10
Amprolium 10
Bexagliflozin 10
Lotilaner 8
Carprofen 8
Frunevetmab 8
Capromorelin 8
Genta/Posacon/Mometa Eardrops 8
Cyclosporine 7
Ilunocitinib 7
Grapiprant 7
Fluralaner Powder For Inj Susp 7
Water, Sodium Chloride 7

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Product defect NOS, 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 (406 here).

Similar death-coded share

Nearest other reactions by death-coded share (2.0% here), distinct from the volume row.

What to do with this reaction

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 NOS (#719 of 2,481 by report volume); death-coded 2.0%. PlainBreed reaction plate · death-coded share stamp 2.0% · 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 →