New incident report
Incident Report Number: 2016-4279
Registrant Reference Number: 2016KP159
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 - Dog
Other (specify)
collarYes
Other Units: collar
Site: Animal / Usage sur un animal domestique
Other
Dog / Chien
Newfoundland
1
Female
3
140
lbs
Skin
>1 wk <=1 mo / > 1 sem < = 1 mois
>3 days <=1 wk / >3 jours <=1 sem
System
Persisted until death
Yes
No
Died
Treatment / Traitement
(eg. description of the frequency and severity of the symptoms
On 17-Jun-2016, the dog exhibited disorientation and the behavior changes of sleeping in a different room, standing in the middle of the street and not coming when her name was called. On 18-Jun-2016, the dog exhibited retching, inappetence and an unspecified eye was swollen. The dog was examined by a veterinarian and no treatments were performed. On 19-Jun-2016, the dog exhibited lethargy, polydipsia and anorexia. The dog was not re-examined by a veterinarian and the signs continued. Follow up received on 28 Jun 2016: On 17-Jun-2016, the dog exhibited disorientation, lethargy, ataxia and the behavior changes. The dog was examined by a veterinarian and no treatments were performed. On 18-Jun-2016, the dog exhibited vomiting, retching, inappetence and periocular edema. The dog was re-examined by a veterinarian and no treatments were performed. Physical exam was noted to be within normal limits. On 19-Jun-2016, the dog exhibited polydipsia and diarrhea. The dog was examined by a veterinarian who performed unspecified blood work and a radiograph; the results were within normal limits. On 20-Jun-2016, the dog received unspecified fluids via an unspecified route by the veterinarian. On 21-Jun-2016, the veterinarian repeated an unspecified blood work panel and radiograph. The results were within normal limits. The dog died. No known necropsy was performed.
Death
Reported behavioural disorders and lethargy are unspecific and may have numerous other causes. Signs may occur initially after collar administration but are not expected to appear after long time. Ataxia is not anticipated with appropriate topical product administration. Even with oral product exposure which was not reported only transient gastrointestinal signs but no neurological signs would be expected. Reported digestive disorders are also unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). Periocular oedema is not expected after product application as sign is not in line with pharmaco toxicological product profile. Death is also not expected after 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. Animal health status and medical history is unknown. Even though time to onset is consistent for initially reported signs, considering long time to onset for later observed signs and death and taking into consideration the known product profile a product relation is unassessable.