Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-7148
2. Registrant Information.
Registrant Reference Number: 120168883
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.
06-DEC-12
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
06-DEC-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 December 5, 2012 the owner applied the product to the cat to prevent fleas.
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
Maine Coon
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.46
7. Weight (provide a range if necessary )
2.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
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
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 December 6, 2012 the owner noticed that the cat was symptomatic. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk was for gastrointestinal (GI) upset if the cat ingested the wet product or for a dermal reaction. The APSS veterinarian also stated that GI signs would not be expected over 24 hours after product application. The APSS technician recommended that the owner monitor the cat at home for continued vomiting and take the cat to the veterinarian if the vomiting continued.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.