Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0149
2. Registrant Information.
Registrant Reference Number: 160156128
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.
19-OCT-16
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
Unknown
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. 31983
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution for Dogs Between 4.6 and 11 kg
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).
Between July 30, 2016 and August 1, 2016 the owner applied the product onto the dog for prevention. On October 10, 2016 the owner once again applied the product onto the dog for 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
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
8.0
7. Weight (provide a range if necessary )
6.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Erythema
- Symptom - Hives
- Symptom - Pruritus
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
Between July 30, 2016 and August 1, 2016 the dog developed symptoms. On September 20, 2016 the owner took the dog to the veterinarian, who gave the dog an antibiotic. On October 19, 2016 the owner contacted the Animal Product Safety Service (APSS) and stated that the dog's signs were still occurring. The APSS veterinarian stated risk is for mild dermal irritation in sensitive animals and she would have expected signs to resolve by now (if related to product sensitivity). The APSS assistant recommended taking the dog to the veterinarian and having the veterinarian call for information.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here