Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-6302
2. Registrant Information.
Registrant Reference Number: 2013CK073
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.
21-OCT-13
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. 11556-143
Product Name: K9 Advantix II Large Dog
- Active Ingredient(s)
- IMIDACLOPRID
- Guarantee/concentration 8.8 %
- PERMETHRIN
- Guarantee/concentration 44 %
- PYRIPROXYFEN
- 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 unspecified date in 2012, a 14 year old, 40 pound, male, Dachshund canine, in unknown condition, with no known concomitant medical conditions, was administered a partial tube of K9 Advantix II Large Dog (Imidacloprid-Permethrin- Pyriproxyfen) once topically by the owner. This was an underdose for this patient.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Dachshund
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
40
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
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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 unspecified date in 2012 the dog passed away from unknown causes. It is unknown if a necropsy was performed. No further information expected. Case closed. Note: The dog had tolerated previous applications well. The reporting person did not call Bayer to report the death of the patient but to ask about the expiry date of the product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Death is not expected in dogs after product application, as inconsistent with pharmaco-toxicological product profile. Very low level of information (medical history and time to onset unknown - necropsy not available) as the intent of the phone call to Bayer several months after the event was to inquire about the expiry date of the product, and not to report the death of the patient. Other etiologies are more probable. It is known, that the dog had tolerated previous product applications well. Considering all aspects, a product connection is deemed to be unlikely.