Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0179
2. Registrant Information.
Registrant Reference Number: 160086229
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.
15-JUN-16
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
14-JUN-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. 31367
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerspot with Smart Shield F&T Control For Dogs Under 14kg
- 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 June 14, 2016 the owner applied the product onto 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
Shih Tzu
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
14.0
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
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
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 June 14, 2016 the dog developed symptoms. Later that day, the owner clipped the dog's hair and bathed (shampoo) the dog. Later that evening the owner took the dog to the veterinarian where they gave the dog diphenhydramine. On June 15, 2016 the owner called the APSS. The APSS veterinarian stated signs are consistent with a paresthesia like reaction. The APSS veterinarian also stated may get relief with cool compressess, application of vitamin E oil. The APSS technician recommended bathing the dog (with liquid dish washing detergent (LDWD), applying a cold compress and vitamin E (at application site), monitoring for dermatological signs, and calling 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
Signs were expected to be mild and self-self limiting.