Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3001
2. Registrant Information.
Registrant Reference Number: 2014CK223
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.
17-JUL-14
5. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
Unknown
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: K9 Advantix unknown
- 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.
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 an unknown date in approximately 2003, a 7 year old, 18 pound, neutered, male, Bichon Frise canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix (unspecified) (Imidacloprid - Permethrin) topically by the owner. This was the first time of use with the product.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
bichon frise
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
18
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Approximately 2 hours following application the dog was hyperactive.Approximately 24 hours later the dog recovered.On an unknown date in approximately 2012 the dog passed away from unknown causes. 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
Behavioural disorders described very unspecific, however may be a consequence of the uncomfortable feeling caused by the applied product. Death is not expected after product application. Time to onset very long (9 years later), therefore allergic/anaphylactic reaction can be ruled out. Death likely related to a concomitant medical status, or to old age, as the dog was then 16 years old. The owner was not calling to report the death but had product questions. Considering all aspects, product relation is deemed to be unlikely.