New incident report
Incident Report Number: 2018-5527
Registrant Reference Number: USA-BAYERBAH-2018-US0055068 (Report 521522)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
Domestic Animal
Country: UNITED STATES
Prov / State: CALIFORNIA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto collar
Other (specify)
COLLARYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
No
Animal's Owner
Dog / Chien
Miniature Schnauzer
1
Female
12
9.07
kg
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
Persisted until death
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 24-Aug-2018, the dog developed anorexia and ataxia. The dog was not evaluated by a veterinarian, no treatment was done, and the clinical signs continued. On 30-Aug-2018, the dog died of unknown causes. No necropsy was performed.
Death
O - Unclassifiable/unassessable Reported anorexia is unspecific and may have numerous other causes. Sign may occur initially after collar administration. Ataxia is not typically seen with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs are expected. Moreover, sign may reflect a mere behavioral reaction to the collar than a true neurological condition. Time to onset is short for these signs. Further, death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Oral exposure to the collar is not expected to cause serious signs either. An overdose of 5 collars around the neck was investigated in adult cats and dogs for an 8 months period and in 10 week old kittens and 7 week old puppies for a 6 months period without causing serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. Time to onset is long. Other causes must be considered in this geriatric dog. Overall, considering all aspects a product involvement is unassessable.