Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4717
2. Registrant Information.
Registrant Reference Number: 2013CP085
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.
27-JUN-13
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
22-JUN-13
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. 27659
PMRA Submission No.
EPA Registration No.
Product Name: K9advantix100
7. b) Type of formulation.
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).
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
pit bull cross
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
30
kg
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
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Skin
- Symptom - Irritated skin
- Specify - scratching
- Nervous and Muscular Systems
- Symptom - Difficulty walking
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
3
Day(s) / Jour(s)
15. Outcome of the incident
Euthanised / Euthanasie
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
Dog was scratching at application sites within 3 hours of application. Owner gave a bath on June23. Scratching resolved on June 26. On June 25, dog developed weakness in hind end. On June 26, dog was examined and showed decreased proprioception in both hind legs and losing balance. On June 27, dog was sent to a neurologist. He was sedated in order to be examined as he was very anxious and had spinal X rays that were normal; on June 28 dog had a CT scan that showed circular lesions in brain. An ultra sound showed lesions in lungs; on June 30 dog became unable to walk and was euthanized; gross post mortem show lesions in brain and lungs; final autopsy result showed metastatic neoplasia in brain and lung.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here