Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-0093
2. Registrant Information.
Registrant Reference Number: 150137609
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-OCT-15
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
04-OCT-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 October 2, 2015 the owner applied the product onto the cat to treat for fleas.
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 )
6.0
7. Weight (provide a range if necessary )
5.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- General
- Symptom - Licking
- Specify - Licking Lips
- Nervous and Muscular Systems
- General
- Symptom - Lethargy
- 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.
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 October 4, 2015 the cat started licking his lips. On October 5, 2015 the cat had a seizure and then developed lethargy and a behavior change (clingy). Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated some animals exhibit abnormal behavior in response to the skin sensation caused by dermal application. The APSS assistant recommended taking the cat to the veterinarian and having the veterinarian call for information. The owner stated she was waiting for a non-profit organization to get the funding together to treat the cat, but she had not received the go ahead from the organization yet.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.