Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0121
2. Registrant Information.
Registrant Reference Number: 120099748
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.
19-JUL-12
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
19-JUL-12
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 July 18, 2012 the owner applied the product to the under label aged dog to prevent fleas.
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Rottweiler
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.33
7. Weight (provide a range if necessary )
20.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- 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.
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 July 19, 2012 the owner noticed that the dog was symptomatic.The employee asked the APSS assistant to call the owner for more information. The APSS contacted the owner to continue the case, but could only leave a voicemail message with the recommendations to take the dog to the veterinarian, have the veterinarian call for information, 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
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On July 20, 2012 an APSS assistant called the owner to update the case. The owner stated that he bathed the dog with liquid dish washing detergent (LDWD) twice on July 19, 2012, once in the morning and once in the afternoon. The owner also stated that on the morning of July 20, 2012 the dog had fully recovered.