Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2021-0822
2. Registrant Information.
Registrant Reference Number: 2020-CA-000416
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: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
11-DEC-20
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
11-DEC-20
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. 26413
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Double Action Flea and Tick Shampoo for Cats and Dogs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .1 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 1.5 %
- PYRETHRINS
- Guarantee/concentration .15 %
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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).
Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Pug and French Bulldog mix
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
9.072
kg
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
<=15 min / <=15 min
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.
No
14. a) Was the animal hospitalized?
No
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 11-Dec-2020 the animal owner bathed the dog with the product and may have ingested 1-2 licks of the shampoo during bathing. The dog developed became symptomatic immediately following the bath. No further information is expected.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews. Symptoms expected to be mild and self-limiting.