Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-0185
2. Registrant Information.
Registrant Reference Number: 2014CK442
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
12-NOV-14
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
08-NOV-14
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. 25129
PMRA Submission No.
EPA Registration No.
Product Name: Advantage 18
7. b) Type of formulation.
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).
A 7yr 10month old FS 4.66kg Siamese cat was treated with 1 tube of Advantage 18. The product was applied topically to the back of the neck by veterinary staff at a veterinary clinic. The cat had a history of fleas, pruritus and alopecia and papules on the abdomen. Assymetrically sized kidneys were also identified on physical examination by the veterinarian.
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
siamese
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
4.66
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
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
12. How long did the symptoms last?
Persisted until death
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
Fully Recovered / Complètement rétabli
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 November 8th 2014, the pet was found dead in the home. A necropsy was not performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Permission was granted for a necropsy but the cat was accidentally cremated. The veterinarian did not believe the death of the pet was related to the advantage.