Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-7007
2. Registrant Information.
Registrant Reference Number: 170148705
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.
27-AUG-17
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
27-AUG-17
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. 31980
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution For Cats 4 kg And Under
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
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 August 26, 2017 the owner applied the wrong dose of product to the cat to treat a condition.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair Cat
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
15.0
7. Weight (provide a range if necessary )
10.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Loss of appetite
- Specify - Inappetence
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 August 27, 2017 the cat developed symptoms. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that imidacloprid is an insecticidal agent that has a wide margin of safety in mammals. The APSS veterinarian also stated that it kills insects by binding to the nicotinic acetylcholine receptors in the insect nervous tissue, which are much more prevalent than in mammals. The APSS assistant recommended the owner take the animal to a veterinarian (for evaluation), have the veterinarian call for information, and to call 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
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. Signs were expected to be mild and self-limiting. The wrong dose of the product was used on the cat, off label use.