Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0127
2. Registrant Information.
Registrant Reference Number: 160069574
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.
16-MAY-16
5. Location of incident.
Country: CANADA
Prov / State: MANITOBA
6. Date incident was first observed.
14-MAY-16
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 (30 lbs)
- 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 May 14, 2016 the owner applied the product for the first time 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
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3.0
7. Weight (provide a range if necessary )
7.0
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
- General
- Symptom - Lethargy
- Symptom - Abnormal behaviour
- Specify - Behavior Change
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 May 14, 2016 the dog developed symptoms. Later that night, the owner bathed the dog (dog shampoo) and provided supportive care (Tahitian noni juice). On May 15, 2016 the dog's symptoms had resolved. On May 16, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated no life threatening signs expected, but the product can cause a pins and needles sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. The APSS veterinarian finally stated some dogs will develop erythema and pruritis as well. The APSS assistant recommended calling back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
No significant signs were expected.