New incident report
Incident Report Number: 2021-3793
Registrant Reference Number: USA-BAYERBAH-2021-US0027561 (Report 709380)
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 small dog
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Unknown
Animal's Owner
Dog / Chien
Shih Tzu
1
Male
Unknown
Unknown
Skin
Unknown / Inconnu
<=30 min / <=30 min
System
Unknown / Inconnu
No
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 30 minutes post collar administration, the dog developed hind limb paralysis. The animal owner consulted with their veterinarian, who recommend the animal owner remove the collar and give the dog a bath. The animal owner removed the collar and gave the dog a bath. Approximately 30 minutes post onset of the clinical sign, the dog recovered without medical intervention. No other treatments were performed. On approximately 01-Jun-2019, the dog died. No necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained nor will they be sought. No further information is expected. This case is closed.
Death
O - Unclassifiable/unassessable Hind limb paralysis and later reported death are not expected following appropriate topical product application as inconsistent with products pharmacological profile. Oral exposure to the collar is not expected to cause such 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. Moreover, collar was applied previously and was well tolerated. Though time to onset is short for hind limb paralysis, other causes must be considered. Further, hind limb paralysis resolved shortly after collar removal and having a bath, which may be co-incidental. Death was reported very long time (about one year) after collar removal, thus other unrelated causes are more probable. No necropsy was performed, and no serious signs reported in close proximity to death either. Also, animal's health status, age and medical history, if any, are unknown. Considering overall aspect, a product relation to the case is unassessable