Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-4071
2. Registrant Information.
Registrant Reference Number: 2015KP098
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Mississauga
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.
20-JUL-15
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
05-OCT-11
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. Unknown
Product Name: Advantage II unknown cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 approximately 01-Oct-2011, a 15 year old, neutered, female, Domestic Short hair feline, of unknown weight, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) topically by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
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 )
15
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
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 approximately 05-Oct-2011, the cat died. The cat was not examined or treated by a veterinarian. A necropsy was not preformed. The veterinarian contacted Bayer Animal Health to inquire about another product not to report the death of this cat. No further information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The information regarding the death of the cat was casually provided during an inquiry. The level of information is extremely low. Nevertheless death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. The cat died of old age. The veterinarian contacted Bayer Animal Health to inquire about another product not to report the death of this cat. Considering all aspects, a product connection is considered to be unlikely.