Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-7744
2. Registrant Information.
Registrant Reference Number: 2016MA225
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 2920 matheson BLVD
City: Mississaugua
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.
31-OCT-16
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
30-OCT-16
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 - size unknown
7. b) Type of formulation.
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 October 29th an owner applied an unknown dose of K9 advantix II topically to an adult cat of unknown sex, age and weight.
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Seizure
- Symptom - Trembling
- Symptom - Abnormal gait
12. How long did the symptoms last?
Unknown / Inconnu
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
Unknown/Inconnu
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
By October 30th in the morning the cat was brought in to the veterinarian for seizures (though it is possible that what was described as seizures were, in fact, tremors). The cat was treated with diazepam and was anesthetized with propofol. On October 31st the cat was taken off propofol and was no longer tremoring or having seizures but was dull and unable to walk (weak) more than a few steps. Prednisone was given on October 31st, a bath with soap was given and feeding a high fat diet was recommended. The cat was improving and it was recommended for owner to consider a neurology consult. Lost to follow up after Nov 2nd.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here