Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0004
2. Registrant Information.
Registrant Reference Number: 120104233
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-JUL-12
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-JUN-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.
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 June 16, 2012 the owner applied an unknown amount of the product to the cat.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Feline Domestic Unspecified
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 )
13.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Discolouration
- Specify - cats lips had turned almost black in color
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.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement rétabli
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 June 17, 2012 the owner noticed that the cat's lips had turned almost black in color. On June 24, 2012 the owner observed that the cat had fully recovered. On July 27, 2012 the owner contacted the company to obtain help. The company's veterinarian stated that topical use of synthetic pyrethroid-like flea preparations as per label instructions is not expected to cause significant clinical signs.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The company's veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.