Reaction profile
The FDA adverse-event record for product defect, general
8,459 FDA reports name product defect, general, a high-volume reaction in the CVM extract (VeDDRA 99021). Plate stamps and neighbourhood peers follow.
- #53 of 2,481
- by report volume (all reactions)
- 8,459
- reports citing this reaction
- 0.7%
- 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, General has 8,459 reports now versus 8,459 in that prior snapshot: 0 the same number of (0.0%).
- Report change
- +0
- Death-coded reports
- +0
- 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, General changesFDA AER · VeDDRA plate
Code 99021 VOL-HIGH
VOL-HIGH · DEATH-RARE · TOP-DECILE · PHOTO-FINISH · SPECIES-UNKNOWN · DRUG-LEAD · DESK-WIDE · BOOK-FULL
- VOL-HIGH 8,459 reports
- DEATH-RARE 0.7%
- TOP-DECILE #53/2481
- PHOTO-FINISH Loose stool
- SPECIES-UNKNOWN Unknown · 7,376
- DRUG-LEAD Fluralaner Chew T… · 1,210
- DESK-WIDE 20 breeds
- BOOK-FULL 8/8 fields
Nearest volume peer: Loose stool (±25 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, General
Upper-third volume poles plus nearest peers, not a full reaction corpus board reprint.
Product Defect, General: low death-coded share in the FDA AER plate
Signature read: 8,459 reports place Product Defect, General in the upper third of FDA AER volume (#53 of 2,481). Report volume is upper-third scale: 8,459 named reports in the openFDA extract. Death-coded share is lower-third: 63 of 8,459 reports (0.7% of named reports). Nearest volume peer: Loose stool (±25 reports). Lead species Unknown (7,376). Lead co-reported drug Fluralaner Chew Tablets (1,210).
Read these counts as reporting volume, not risk: per our methodology, Lead co-reported drug Fluralaner Chew Tablets 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
Breeds Most Affected
Associated Drugs
Nationwide reactions with similar profiles
Two openFDA-derived peer sets for Product Defect, General, 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 (8,459 here).
Similar death-coded share
Nearest other reactions by death-coded share (0.7% here), distinct from the volume row.
What to do with this reaction
- Compare Product Defect, General'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
Informational only. FDA adverse-event reports are voluntary and do not prove causation; consult a veterinarian before acting on them. Verify with FDA CVM →