Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0050
2. Registrant Information.
Registrant Reference Number: 090001732
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.
05-JAN-09
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
01-JAN-09
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. 26496
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On 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 January 1, 2009, the owner applied the product to his cat.
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 Cat
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
9
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom -
- Specify - Excessive Grooming
- Skin
- Symptom - Itchy skin
- Symptom - Irritated skin
- Specify - Rubbing Application Site
- General
- Symptom - Lethargy
- Symptom - Hair loss
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Anorexia
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
Not recovered / Non 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
The APSS technician, per the APSS veterinarian, recommended that the owner bathe the cat with liquid dish washing soap, apply vitamin E to the application site, 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
Upon follow up, it was determined that the excessive grooming, pruritis, and rubbing the application had ended on January 6; and the anorexia ended on January 8; as of January 12, the lethargy was still present, although improved. The owner monitored at home, gave the pet a bath, and applied vitamin E, but did not call back with questions. The APSS technician recommended the owner contact the manufacturer in regard to specific questions concerning statistics and the product.