Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-6710
2. Registrant Information.
Registrant Reference Number: 2016KP268
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.
18-OCT-16
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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
- 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 unspecified date in 2015, a 8 year old, male, Unknown Breed feline, of unknown weight and condition, no concomitant medical conditions, was administered unknowndose of (s)-methoprene topically by the owner. Also on unspecified dates in 2015 the cat was administered Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner. On an unspecified date in 2016, the cat developed pruritus and fleas.O n 09-Sep-2016, the cat was administered an unknown dose of a cortisone injection by the attending Veterinarian. The cat also had 1 Seresto Cat (Flumethrin-Imidacloprid) collar placed around the 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
Unknown
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
8
7. Weight (provide a range if necessary )
Unknown
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
Unknown / Inconnu
11. List all symptoms
System
- Respiratory System
- Symptom - Difficulty Breathing
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 an unspecified date in 2015, a 8 year old, male, Unknown Breed feline, of unknown weight and condition, no concomitant medical conditions, was administered unknown dose of (s)-methoprene topically by the owner. Also on unspecified dates in 2015 the cat was administered Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Pruritus occurred before the product application, hence not related to the product. Reported breathing difficulty and subsequent 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 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. Anaphylactic reaction can not be ruled out as sign occurred in close proximity to the collar application. Time to onset short. Considering the product profile, product involvement is deemed unlikely, however due to short time to onset and missing necropsy details, case is considered unassessable.