Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-3053
2. Registrant Information.
Registrant Reference Number: 2014CK275
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 II unknown
- 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.
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 2011, a 16.5 year old, neutered, female, Shih Tzu canine, of unknown weight, in good condition with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (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?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
shih tzu
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
16.5
7. Weight (provide a range if necessary )
Unknown
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
- Renal System
- Symptom - Other
- Specify - unknown renal disorder
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 unknown date post application, the dog exhibited decreased renal values. Approximately four months after application, bloodwork was performed and the renal values returned to within normal limites. On 18-Nov-2013, the dog died. No known necropsy was performed
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Renal disorders are not expected after product application as inconsistent with pharmaco-toxicological profile of the product. Time to onset unknown. However the values are return to normal values 4 months after product application. Product involvemet is unlikely. Death not expected in dog after product application, as inconsistent with pharmacotoxicological product profile. However old age of dog, history of renal disorders and other etiologies more probable. Date of death (2 years later) too long and no necropsy available. Considering all aspects and time to onset, a product connection deemed to be unlikely.