Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0073
2. Registrant Information.
Registrant Reference Number: 100045368
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-APR-10
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
12-APR-10
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. 26493
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Power Spot Flea and Tick Control for Dogs Over 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2
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 April 12, 2010 the owner applied the product to the dog.
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
Dog / Chien
3. Breed
Canine Domestic
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.5
7. Weight (provide a range if necessary )
65
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
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?
>8 hrs <=24 hrs / > 8 h < = 24 h
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Fully Recovered / Complètement 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 April 12, 2010 the owner took the dog to the veterinarian, where they bathed the dog and administered methocarbamol. On April 13, 2010 there was a change to the dog's symptoms, so the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that signs should be self limiting. The APSS veterinarian recommended bathing the dog with liquid dish washing detergent (LDWD), applying Vitamin E at the application site once the dog is mostly dry, monitoring at home, and calling back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
On April 19, 2010 an APSS technician contacted the owner to follow up the case. The owner stated that she had bathed the dog with LDWD immediately after the APSS consultation and monitored the dog at home, but she did not apply the Vitamin E to the dog. The dog's signs ended after the bath.