New incident report
Incident Report Number: 2020-2824
Registrant Reference Number: USA-BAYERBAH-2020-US0026352 (Report 642204)
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: ILLINOIS
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large Dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Crossbred (German Boxer x Great Dane)
1
Male
10
63.503
kg
Skin
>1 mo <= 6 mos / > 1 mois < = 6 mois
>1 wk <=1 mo / > 1 sem < = 1 mois
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On approximately 30-Apr-2020, the dog exhibited ataxia and tremors. On 05-May-2020, the dog died. The dog had not been evaluated by a veterinarian and during burial the owner noted an application site rash under the collar. No necropsy was performed. No more information is expected. This case is closed. No quality issues were noted upon product investigation.
Death
O - Unclassifiable/unassessable Reported neurological signs are not typically seen with appropriate topical product administration. Further, reported application site rash may occur in sensitive animals after product application. It is usually mild and transient. Unclear if correct fit of collar was checked periodically as recommended in the product information and thus development of signs not noticed. 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. This is supported by the extremely low systemic exposure with imidacloprid and flumethrin, particularly during the first week after application and also thereafter. Other causes are more probable, although not described. Time to onset is long. In this case, product involvement is deemed to be unlikely. However considering limited information such as necropsy details, health status etc. case is considered unassessable.