Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-2748
2. Registrant Information.
Registrant Reference Number: 2016KP066
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
04-MAY-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
29-DEC-15
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No.
PMRA Submission No.
EPA Registration No. 11556-155
Product Name: Seresto Collar - Cat
- Active Ingredient(s)
- Flumethrin
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
Collar
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
10. Site pesticide was applied to (select all that apply).
Site: Animal / Usage sur un animal domestique
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On an unknown date in approximately Oct 2015, a 10.5 year old, 5.9 pound, neutered, female, Domestic Shorthair feline,in unknown condition, with no known concomitant medical conditions, had 1 Seresto Cat collar (Flumethrin-Imidacloprid)placed around her neck by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.5
7. Weight (provide a range if necessary )
5.9
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>1 mo <=2 mos / > 1 mois < = 2 mois
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Salivating excessively
- Blood
- Symptom - Other
- Specify - Septicaemia
- Skin
- Symptom - Other
- Specify - Granuloma
- Blood
- Symptom - Other
- Specify - Lymphadenitis
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
16. How was the animal exposed?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On 29Dec2015, the cat began hypersalivating and the collar was removed. On 05Jan2016, the cat passed away. A necropsy was performed and revealed sepsis, granulomas throughout her lungs and abdomen, and enlarged lymph nodes. No more information expected. Case closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Hypersalivation is unspecific and may have numerous other causes (e.g. gastrointestinal infection, dietary incompatibility). No oral product exposure. Time to onset long. Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile and is even not expected following oral exposure. Time to onset long. 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. Death was likely consequence of sepsis. More over cat died after collar removal. Reported necropsy findings, sepsis, granulomas throughout lungs and abdomen, and enlarged lymph nodes are not expected with appropriate topical product administration as not inline with pharmaco-toxicological product profile. Cat involved in this case was geriatric. Time to onset is
not suggestive of product relation. In the end, a product connection deemed to be unlikely.