Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-4050
2. Registrant Information.
Registrant Reference Number: 2015KP077
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.
14-SEP-13
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. 11556-152
Product Name: Advantage II large 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.
.8
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 31-Aug-2013, a 13 year old, 12.00 pound, neutered, male, Domestic Shorthair feline, in good condition, with no known concurrent medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once 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
Male
6. Age (provide a range if necessary )
13
7. Weight (provide a range if necessary )
12
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
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Edema
- Specify - Oedema NOS
- Symptom - Other
- Specify - Suspected infectious agent transmission
12. How long did the symptoms last?
>1 wk <=1 mo / > 1 sem < = 1 mois
13. Was medical treatment provided? Provide details in question 17.
Yes
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 14-Sep-2013 the cat exhibited a swelling on it's side. It was seen by a veterinarian and diagnosed with Feline infectious peritonitis and pleural effusion. Update 18.04.2015: The cat died, it is unknown if he was euthanized or if a necropsy was performed. No further information is not 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 communicated 18 months after the incident. Reported clinical signs are unlikely product-related as inconsistent with the pharmacological and toxicological product profile. Time to onset with 14 days too long. Feline Infectious Peritonitis and pleural effusion were diagnosed. Death most likely a consequence of the FIP. A transmission of the FIPVirus can be excluded as product is a chemical product without any biological component or biological process step. A relation to the product is therefore unlikely.