Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0236
2. Registrant Information.
Registrant Reference Number: 090113062
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.
08-OCT-09
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
25-SEP-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. 26413
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Double Action Flea and Tick Shampoo
- Active Ingredient(s)
- (S)-METHOPRENE
- PIPERONYL BUTOXIDE
- PYRETHRINS
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.
Unknown
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 September 25, 2009 the owner used the Zodiac Fleatrol Double Action Flea and Tick Shampoo and applied the Zodiac Spot On Flea Control for Cats and Kittens on the cat. The other again bathed the cat with Zodiac Fleatrol Double Action Flea and Tick Shampoo and applied the Zodiac Spot On Flea Control for Cats and Kittens on September 29, 2009. A flea spray was also used October 1, 2009 through October 4, 2009.
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
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Mediumhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
10
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 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.
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
On October 8, 2009 the APSS veterinarian stated that if the cat licked up some of the foam, drooling and a bad taste reaction can occur. She also stated that some cats will object to sensation of a spot on product spreading on the skin. She further stated that this product would not cause a paresthesia type reaction. The APSS veterinarian recommended that the owner monitor the cat at home, bathe the cat with a non-insecticide mild shampoo, and call back with questions. She also recommended that the owner take the cat to the veterinarian if signs do not resolve and have the veterinarian call for information.
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 Zodiac Fleatrol Double Action Flea and Tick Shampoo was considered to have a doubtful likelihood of causing the clinical situation. An APSS technician contacted the owner to follow up the case on October 16, 2009. The owner reported that the pruritus continues, and the cat was not taken to the veterinarian. The product was not used according to label directions: use product only once every 30 days.