Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-7012
2. Registrant Information.
Registrant Reference Number: 170160508
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.
14-SEP-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
31-AUG-17
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. 31984
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution For Cats Over 4 kg
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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 August 24, 2017 the caller inappropriately applied the wrong dose of the product on to the cat to treat a condition.
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
Other
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8.0
7. Weight (provide a range if necessary )
5.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- General
- Symptom - Other
- Specify - Hair Mats
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 August 31, 2017 the cat developed hair mats. The caller believes the area became matted due to the product. When the caller wiped the area while clipping the fur (not able to fully remove the mat), it was the same color as the product. On September 14, 2017 the caller contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that the risk is for possible dermal sensitivity. The APSS assistant recommended the caller take the animal to a veterinarian (to have the skin looked at and the mat shaved), have the veterinarian call for information, and to call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
This was an inappropriate dose of the product on to the cat, off label use. Signs were expected to be mild and self-limiting.