Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-5932
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2019-US0056642 (Report 599424)
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.
20-SEP-19
5. Location of incident.
Country: UNITED STATES
Prov / State: INDIANA
6. Date incident was first observed.
19-SEP-19
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. 27585
PMRA Submission No.
EPA Registration No.
Product Name: advantageII small cat
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 9.1 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Other (specify)
spot-on
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
Units: mL
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 19-Aug-2019, a 21 year old, 9 pound, neutered, female, Domestic Shorthair feline, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
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 )
21
7. Weight (provide a range if necessary )
4.082
kg
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 wk <=1 mo / > 1 sem < = 1 mois
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 19 Sep 2019, the cat exhibited weight loss; fixed dilated eyes and died. No necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Dilated pupils is not typically observed with appropriate topical product administration. Other causes must be considered. Weight loss and death are not expected after product application, as inconsistent with pharmaco-toxicological product profile. An appropriate dosage was applied and no oral product exposure reported. Oral exposure to the product is not expected to cause serious conditions leading to death either. The product was administered to puppies/kittens at up to 5 times the recommended dose, every 2 weeks for 6 treatments and there were no serious safety concerns. Even though no necropsy was performed, other unrelated causes are more likely in this geriatric cat. Considering product profile and long time to onset, product involvement is deemed to be unlikely.