Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0119
2. Registrant Information.
Registrant Reference Number: 120095362
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.
11-JUL-12
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-JUL-12
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 July 11, 2012 the owner applied the product to her cat to prevent fleas. The owner thought that the cat had licked some of the product off of her paw.
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 )
1.0
7. Weight (provide a range if necessary )
8.0
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Behavior Change
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
No
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
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
On July 11, 2012, shortly after the product was applied to the cat, the owner noticed that the cat was drooling and was hissing at her littermate. A short time later that day, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the cat was likely experiencing a bad taste reaction, probably to the carriers. During the consultation with APSS, the owner stated that she had given the cat some treats to help get the bad taste out of the cat's mouth. The APSS assistant recommended that the owner give the cat a taste treat of a couple of teaspoons (tsp) of milk and wipe off the cat's coat and skin to blot any product that might be dripping down from the application site. The APSS assistant also referred the owner to the product's manufacturer to discuss efficacy questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs expected to be mild and self limiting.