Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-6162
2. Registrant Information.
Registrant Reference Number: 2015KP278
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Bvd. 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.
19-OCT-15
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
20-AUG-15
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. 11556-135
Product Name: k9 advantix 55
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2.5
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 an unspeciified date in Dec-2010, a 9 year old, approximately 50 pound, neutered, female, Siberian Husky canine, in good condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix 55 (Imidacloprid - Permethrin) topically by the owner. On 01-Aug-2015, the now 14 year old dog was administered 1 tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) topically 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
Dog / Chien
3. Breed
Siberian Husky
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
9
7. Weight (provide a range if necessary )
50
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- General
- Symptom - Death
- Symptom - Vocalizing
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 20-Aug-2015, the dog began vocalizing. On 21-Aug-2015, the dog died. No necropsy was performed. 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
Beyond the fact that death is not expected in a dog after product application, as it is inconsistent with the pharmaco-toxicological product profile, all signs were reported 5 years after application, therefore a product connection can be ruled out. Other etiologies are more probable. Considering the exceptionally long time to onset (5 years), a product relation is deemed to be unlikely.