Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0342
2. Registrant Information.
Registrant Reference Number: 110148879
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.
22-NOV-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
21-NOV-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 Fleatrol Power Spot 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 November 21, 2011 the owner applied 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
Canine Domestic Unspecified Mix
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
10.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Erythema
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
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 November 21, 2011 the owner noticed that the dog was symptomatic. Later that evening, the owner bathed the dog twice with puppy shampoo, but the baths weren't very effective at relieving the dog's signs. On November 22, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that some dogs may have skin sensitivity and develop an itching or tingling sensation at the application site, causing them to scratch and potentially causing secondary hair loss. The APSS veterinarian recommended that the owner bathe the dog with liquid dish washing detergent (LDWD) and warm water, apply vitamin E to the dog, and give 25 milligram (mg) capsules of Diphenhydramine to the dog.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs expected to be mild and self limiting.