Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-5402
2. Registrant Information.
Registrant Reference Number: 150107350
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.
06-AUG-15
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
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. 28743
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On II Flea Control For Cats And Kittens
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).
On July 30, 2015 the owner applied the product onto the cat, who was heavily flea infested.
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
Cat / Chat
3. Breed
Feline Domestic Unspecified
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
25.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Withdrawn
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
Died
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
Starting on an unknown date, the cat developed symptoms. On August 1, 2015 the cat was found dead in the neighbor's yard. On August 6, 2015 the owner contacted the company and stated that he is having a necropsy done locally and then is willing to submit the necropsy results. No other details at this time. The company veterinarian stated topical use of synthetic pyrethroid-like flea preparations as per label directions is not expected to cause significant clinical signs.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The company veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A follow up was not performed, because the owner said he would follow up with the company after the necropsy is done. On August 15, 2015 an Animal Product Safety Service (APSS) technician called and left a message for the owner to discuss the necropsy results. Therefore, the necropsy results of this case are unknown.