Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4538
2. Registrant Information.
Registrant Reference Number: 2013AM217
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.
13-AUG-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. 11556-132
Product Name: K9 Advantix 10
- 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.
.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).
One vial of K9 Advantix 10 was applied topically by the owner to one spot on the dorsal midline.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Shih tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
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 unknown date in 2012, a 5 year old, male, Shih Tzu canine of unknown weight, in unknown condition, with no known medical conditions, was administered 1 tube of K9 Advantix 10 (Imidacloprid - Permethrin) once topically by the owner. On an unknown date post application in 2012 the dog was hit by a car and died. No necropsy was performed. The reporting party initially contacted Bayer to inquire about using this product on different pet and not to report this event. No more information is expected and the 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
A product connection seems unlikely since death was caused by a car accident. Though onset time is not known, product involvement was ruled out since reporter did not suspect product involvement was he called Bayer due to other reasons.