New incident report
Incident Report Number: 2019-3609
Registrant Reference Number: USA-BAYERBAH-2019-US0033914 (Report 575930)
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: NORTH CAROLINA
PMRA Registration No. PMRA Submission No. EPA Registration No. 11556-155
Product Name: Seresto Large dog collar
Other (specify)
COLLARYes
Other Units: COLLAR
Site: Animal / Usage sur un animal domestique
Animal's Owner
Dog / Chien
Border Collie
1
Female
8
16.8
kg
Skin
>15 min <=2 hrs / >15 min <=2 h
<=30 min / <=30 min
System
Unknown / Inconnu
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
Approximately 30 minutes post application, the dog exhibited application site swelling, facial swelling, swelling around the eyes, and was unable to blink. The Seresto and identification collars were removed from the dog, then alternating warm and cold compresses were applied to the swollen areas. Approximately 1 hour post application, the swelling ruptured, then blood and discharge were drained. The dog was evaluated by a veterinarian, then started on an unspecified pain medication and unspecified antibiotics. The owner cleaned the ruptured area and applied fish oil to it. On 22-Jun-2019, the dog was anorexic. On 24-Jun-2019, the dog exhibited hematemesis and died. No known necropsy was performed.
Death
O - Unclassifiable/unassessable - Reported application site swelling and facial swelling are in line with a hypersensitivity reaction however product has very low allergic potential. But allergic reactions are possible to any product. No alternative cause described. Swelling around the eyes and unable to blink are likely associated with allergic reaction. Abscess is not expected after product administration. Further reported anorexia is an unspecific and may have numerous other causes. Hematemesis and death are not expected either after collar application as inconsistent with product's pharmacological profile. No oral product exposure reported. 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. Even though time to onset is short for initial reported signs but later reported signs were occurred after collar removal. Other unrelated causes must be considered in this case. Considering the product profile, product involvement is deemed unlikely regarding serious signs, and other causes were considered more likely, however due to limited information (regarding state of health, medical history and necropsy are unknown), a relation to this case is considered as unassessable.