Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6956
2. Registrant Information.
Registrant Reference Number: 180075687
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.
05-MAY-18
5. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
05-MAY-18
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. 31984
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution For Cats Over 4 kg
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
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 May 5, 2018 the owner applied the 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?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.88
7. Weight (provide a range if necessary )
10.5
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 / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Salivating excessively
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
Fully Recovered / Complètement rétabli
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
Shortly after the product was applied on May 5, 2018 the cat developed symptoms. A few hours later, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that taste reaction to scent or taste may be seen. The APSS assistant recommended the owner monitor at home, give a taste treat, monitor for gastrointestinal signs, 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
On May 7, 2018 an APSS assistant called to follow up on the case. The owner stated that the hypersalivation resolved shortly after speaking with APSS on May 5, 2018. Soon after that on May 5, 2018, the owner applied an Elizabethan collar (E-collar). Finally, the owner stated that the lethargy had resolved on May 6, 2018 and that the cat is now fully recovered. Signs were expected to be mild and self-limiting.