Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0040
2. Registrant Information.
Registrant Reference Number: 090144237
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.
29-DEC-09
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
27-DEC-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 November 26, 2009 and again on December 26, 2009 the owner applied the product to the 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 Longhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
10
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
- Skin
- Symptom - Dermatitis
- Symptom - Erythema
- Symptom - Hair loss
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 27, 2009 the owner noticed the cat trying to lick the affected or treated area, but was unable to reach it. On December 29, 2009 the APSS veterinarian stated the signs could reflect an acquired hypersensitivity to the product, either the active component or to the carrier. The APSS technician relayed the APSS veterinarian's recommendations to bathe the cat with liquid dish washing detergent, then keep him warm and dry, monitor for dermatological signs, take the cat to the veterinarian if the signs worsen, and 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