Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-0957
2. Registrant Information.
Registrant Reference Number: 110106682
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.
18-AUG-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
17-AUG-11
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. 26494
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
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 August 13, 2011 the owner applied 1.0 mL of the product to the dog to treat for fleas.
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
Toy Poodle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
4.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Erythema
- Nervous and Muscular Systems
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
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 August 17, 2011 the owner noticed the dog was symptomatic. On August 18, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that there was a low risk of dermal irritation and that the signs fit with a paresthesia reaction. The APSS assistant recommended that the owner bathe the dog with liquid dish washing detergent (LDWD), apply vitamin E to the application site, provide thermoregulation, monitor the dog at home, consult with a veterinarian about alternative flea prevention and wait times between products, and call 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 August 24, 2011 the owner contacted the APSS to update the case. The owner stated that at an unknown date and time she had bathed the dog, applied vitamin E to the application site, provided thermoregulation, and monitored the dog at home. The owner also stated that on August 18, 2011 the dog had made a full recovery.