New incident report
Incident Report Number: 2018-6450
Registrant Reference Number: USA-BAYERBAH-2018-US0058569 (Report 525323)
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: CONNECTICUT
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
Animal's Owner
Dog / Chien
Terrier (Rat) canine
1
Female
9
6.35
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 mo <=2 mos / > 1 mois < = 2 mois
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On an unspecified date in Aug2018, the dog developed pacing, panting, and anorexia. On approximately 01Sep2018, the dog was examined by a veterinarian and administered an unspecified amount of subcutaneous fluids. Approximately 4 hours post treatment with the SC fluids, the dog developed twitching, vomited, and died. It is unknown if a necropsy was preformed.
Death
N - Unlikely - Reported pacing and anorexia are an unspecific signs and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Panting is not expected with product use, however may be consequence of reported pacing. Further reported signs reported after long time to onset and shortly after application of other products. Vomiting is an unspecific sign and may have other causes. Twitching is not anticipated with appropriate topical product administration. No oral product exposure reported. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Death is not expected either 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 long. Role of concomitant medicaments must be considered in this case as dog died shortly after application of these products. Overall, a product relation considered as unlikely.