Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-7027
2. Registrant Information.
Registrant Reference Number: 170121590
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.
17-JUL-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
13-JUL-17
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 13, 2017 the owner applied the product to the dog as prevention.
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
Bichon Frise
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 )
9.0
kg
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
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
>2 hrs <=8 hrs / > 2 h < = 8 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
Within a few hours after the product was applied, the dog became symptomatic. Soon after, the owner contacted their regular veterinarian who recommended the owner bathe the dog. A few hours after the bath, the dog started acting normal. On July 17, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrin is a pyrethroid and that dogs tolerate pyrethroids well. The APSS veterinarian stated that no life threatening signs are expected. The APSS veterinarian also stated that pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. Finally, the APSS veterinarian stated that some dogs will develop lethargy as well.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs were expected to be mild and self-limiting.