Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0182
2. Registrant Information.
Registrant Reference Number: 160103856
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-JUL-16
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
15-JUL-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 July 15, 2016 the owner applied the product onto the dog for the first time for treatment.
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 )
8.0
7. Weight (provide a range if necessary )
11.0
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 <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- General
- Symptom - Biting
- Specify - Chewing
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 July 15, 2016 the dog developed symptoms. A short time later the owner gave the dog diphehydramine (2.5 milligrams (mg)). On July 16, 2016 the dog's symptoms resolved. A few hours later the dog's pruritus returned. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated a dermal hypersensitivity reaction is possible and clinical signs may include mild dermatitis and hyperesthesia. The APSS assistant recommended vitamin E (puncture capsule and rub oils in at the application site), bathing the dog (with liquid dish washing detergent (LDWD) - if vitamin E does not seem to offer any relief), calling the veterinarian (contact regular veterinarian (RDVM) to discuss alternate flea preventatives that would not elicit this reaction), 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
Signs were expected to be mild and self-limiting.