Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0044
2. Registrant Information.
Registrant Reference Number: 150120465
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.
01-SEP-15
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
31-AUG-15
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.
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).
On August 31, 2015 the owner applied the product onto the cat as 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
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.417
7. Weight (provide a range if necessary )
7.5
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
- Nervous and Muscular Systems
- General
- Symptom - Abnormal behaviour
- Specify - Behavior Change
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
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
On August 31, 2015 the cat developed symptoms so the owner bathed the cat (straight water). Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian also stated in addition, some animals exhibit abnormal behavior in response to the dermal sensation. The APSS veterinarian finally stated if ingested, gastrointestinal (GI) upset and/or a taste reaction may occur. The APSS assistant recommended monitoring the cat at home, giving the cat a bath (liquid dish washing detergent (LDWD) if owner would like- this is an option, but not absolutely necessary if the cat is acting normal), calling back with questions, and calling the veterinarian (to discuss alternate flea control options).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here