Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-1781
2. Registrant Information.
Registrant Reference Number: 140024144
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
27-FEB-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
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. 28743
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On II Flea Control For Cats And Kittens
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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 unknown date, the owner applied the product to the cat.
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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
10.0
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
- Nervous and Muscular Systems
- Symptom - Fasciculations
- Symptom - Seizure
- Symptom - Other
- Specify - Altered mentation
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?
Unknown
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
On an unknown date, the owner noted the cat began hypersalivating, fasciculating, seizuring and was displaying altered mentation. On October 18, 2013 the owner took the cat to the veterinarian where the cat was treated with diazepam, midazolam, and was also sedated and ultimately euthanized. On February 27, 2014 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal reactions can occur. The APSS veterinarian recommended that the owner have the medical record for the cat faxed to APSS. A necropsy was not available as the cat was buried at home.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Major
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have not related likelihood of causing the clinical situation.