Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-4030
2. Registrant Information.
Registrant Reference Number: 2015KP147
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 Matheson Blvd. East
City: Toronto
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.
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. 11556-144
Product Name: k9 advantix II Extra large dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- Guarantee/concentration .46 %
7. b) Type of formulation.
Liquid
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 an unknown date in approximately 2014, a 6 year old, 90 pound, male, Pointer (German Short-Haired) canine, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II Extra 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
German Short-haired Pointer
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
90
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
- Nervous and Muscular Systems
- Symptom - Unconsciousness
- Specify - Loss of consciousness
- Nervous and Muscular Systems
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 an unknown date post application the dog collapsed with a stroke. The dog died 2 hours later. The dog was not seen by the veterinarian and 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
Note: Dog tolerated previous applications well. Reported signs are not expected as inconsistent with product pharmaco toxicological profile. Death of the dog may be due to stroke reported. Low level of information (time to onset unknown). Time taken for reporting is also too long. Even though dog tolerated previous applications well, other causes are more probable. Overall, considering all aspects, a product connection is deemed to be unlikely.