Reaction profile

The FDA adverse-event record for defect unknown/not specified

1,284 FDA reports name defect unknown/not specified, a high-volume reaction in the CVM extract (VeDDRA 99009). Plate stamps and neighbourhood peers follow.

#321 of 2,481
by report volume (all reactions)
1,284
reports citing this reaction
2.6%
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. Defect Unknown/Not Specified has 1,284 reports now versus 1,266 in that prior snapshot: 18 more (1.4%).

Report change
+18
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 Defect Unknown/Not Specified changes

FDA AER · VeDDRA plate

Code 99009 VOL-MID

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

  • VOL-MID 1,284 reports
  • DEATH-LOW 2.6%
  • UPPER-Q #321/2481
  • PHOTO-FINISH Bruising
  • SPECIES-UNKNOWN Unknown · 876
  • DRUG-LEAD Meloxicam · 150
  • DESK-WIDE 20 breeds
  • BOOK-FULL 8/8 fields

Nearest volume peer: Bruising (±4 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 Defect Unknown/Not Specified

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

Vomiting · highest174348Otitis externa · near1289Bruising · near1288Defect Unknown/Not Sp… · thi…1284Application site infl… · near1270NT - Abnormal necrops… · near1268Urinary tract neoplas… · low…10
FDA AER report volume · neighbourhood around Defect Unknown/Not Specified

Defect Unknown/Not Specified: low death-coded share in the FDA AER plate

Signature read: 1,284 reports place Defect Unknown/Not Specified in the upper third of FDA AER volume (#321 of 2,481). Report volume is upper-third scale: 1,284 named reports in the openFDA extract. Death-coded share is lower-third: 33 of 1,284 reports (2.6% of named reports). Nearest volume peer: Bruising (±4 reports). Lead species Unknown (876). Lead co-reported drug Meloxicam (150).

Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Meloxicam 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 876
Dog 297
Cat 85
Human 13
Horse 6
Cattle 3
Goat 2
Other 1
Sheep 1

Breeds Most Affected

Unknown 892
Dog (unknown) 42
Domestic Shorthair 32
Cat (unknown) 24
Retriever - Labrador 24
Crossbred Canine/dog 22
Retriever - Golden 14
Shepherd Dog - German 13
Shih Tzu 12
Chihuahua 11

Associated Drugs

Meloxicam 150
Cyclosporin Ointment 137
Fenbendazol Granules 133
Insulin Injectable Vial 62
Milbemycin Oxime + Spinosad 61
Fluralaner Spot-On Solution 53
Milbemycin Oxime + Praziquantel 48
Fluralaner Chew Tablets 39
Enrofloxacin 38
Carprofen 35
Oxytetracycline Dihydrate 35
Lotilaner 32
Orbifloxacin Oral Suspension 31
Cyclosporine 29
Imidacloprid + Moxidectin 26
Spinosad 21
Buprenorphine 21
Genta/Momet/Clotrim Ear Oint 20
Febantel + Praziquantel + Pyrantel Pamoate 19
Vetpen Starter Kit 18

Nationwide reactions with similar profiles

Two openFDA-derived peer sets for Defect Unknown/Not Specified, both floored at ≥50 reports so the neighborhoods stay in the advertised mass (the volume chart above is the unfloored photo-finish strip).

Similar death-coded share

Nearest other reactions by death-coded share (2.6% 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 Defect Unknown/Not Specified (#321 of 2,481 by report volume); death-coded 2.6%. PlainBreed reaction plate · report volume stamp 1,284 · 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 →