Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0285
2. Registrant Information.
Registrant Reference Number: 160063414
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.
05-MAY-16
5. Location of incident.
Country: CANADA
Prov / State: NEW BRUNSWICK
6. Date incident was first observed.
04-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 4, 2016 the owner applied the product onto 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
Shih Tzu 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 )
16.0
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
- Nervous and Muscular Systems
- General
- Symptom - Abnormal behaviour
- Specify - Rolling
- Nervous and Muscular Systems
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
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 May 4, 2016 the dog developed symptoms. On May 5, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS assistant stated concerns are for dermal hypersensitivity which occurs in a small percentage of animals, possibly due to carriers in the product, or a tingling sensation (tingling of nerve endings) from the permethrin. The APSS assistant also stated signs of dermal hypersensitivity may include redness, itching, rubbing, biting, and shaking of legs or hindquarters. The APSS assistant recommended bathing the dog (dish soap), applying vitamin E and a cold compress (to the application site), calling the veterinarian (to discuss what to use in the future), and 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.