Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0178
2. Registrant Information.
Registrant Reference Number: 160085066
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.
13-JUN-16
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
10-JUN-16
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 June 6, 2016 the owner applied the product onto the cat for prevention.
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
Feline Domestic Unspecified
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5.0
7. Weight (provide a range if necessary )
15.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
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 June 10, 2016 the owner noticed the cat was symptomatic. On June 11, 2016 the owner bathed the cat (with cat shampoo). On June 13, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal irritation or contact hypersensitivity may occur as with any topical exposure. The owner stated there was no dermal irritation, the cat is not bothering the area, the cat is acting normal otherwise. The APSS technician recommended discontinuing product usage, calling the veterinarian (to discuss alternative flea prevention), and calling 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
Signs were expected to be mild and self-limiting.