New incident report
Incident Report Number: 2016-7956
Registrant Reference Number: 2016KP237
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
Domestic Animal
Country: UNITED STATES
Prov / State: UNKNOWN
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
Other
Dog / Chien
Havaneser
1
Female
0.5
3
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>2 mos <=6 mos / > 2 mois < = 6 mois
System
>3 days <=1 wk / >3 jours <=1 sem
Yes
Yes
2
Day(s) / Jour(s)
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 22Jun2016, the dog collapsed and was in lateral recumbency. The dog was administered an unspecified dose of corn syrup orally by the owner and the clinical signs resolved within approximately 2 hours. On 23Jun2016, the dog developed lethargy. On 24Jun2016, the dog was examined by a veterinarian. It is unknown if any treatments were performed. On 25Jun2016, the dog was examined by an emergency veterinarian and diagnosed with dehydration, a hear murmur, and tapeworms. The dog was hospitalized and administered an unknown dose of intravenous fluids. On 27Jun2016, the dog died. No necropsy was performed. The intent of the initial phone call was to discuss use of a different Bayer product and not to report the death of the patient. No further information is expected. This case is closed.
Death
Reported collapse and lateral recumbency are not expected after topical product application as signs inconsistent with pharmaco-toxicological product profile. Further lethargy is an unspecific sign and may have numerous other causes. Later diagnosed dehydration, heart murmur and tapeworms are not expected either. Further reported death is not expected following appropriate topical product application as inconsistent with products 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. The owner did not believe in product involvement either as the reason for initial call was to discuss use of a different Bayer product and not to report the death of the patient. Other causes are more likely, e.g. heart disease. Although no necropsy performed, considering the known product profile sufficient information exists to conclude that the product did not cause the event and product involvement is unlikely.