Health Canada
www.hc-sc.gc.ca
Common menu bar links
Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-7031
2. Registrant Information.
Registrant Reference Number: 170135584
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.
07-AUG-175. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
01-AUG-17Product 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
- Active Ingredient(s)
- (S)-METHOPRENE
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Units: 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 1, 2017 the owner applied the product to the cat as prevention.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Mediumhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.23
7. Weight (provide a range if necessary )
3.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>2 hrs <=8 hrs / >2 h <=8 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle tremors
- Respiratory System
- Symptom - Panting
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
9
Hour(s) / Heure(s)
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 the evening of August 1, 2017 the cat developed muscle tremors. Shortly after, the owner bathed the cat with dawn dish soap. On the morning of August 2, 2017 the cat started panting and was still having muscle tremors. A couple hours later, the owner took the cat to the regular veterinarian who administered fluids and gave methocarbamol. In the evening on August 2, 2017 the cat's panting ended and soon after, the tremors became more mild. On August 7, 2017 the owner contacted the Animal Product Safety Service (APSS) to report the adverse reaction. The APSS veterinarian stated that this product contains only methoprene (an insect growth regulator). The APSS veterinarian also stated that signs not at all consistent with this agent. Finally, the APSS veterinarian stated that the owner needs to find out if there was any possible exposure to a dogs-only spot on product, as reported signs could be seen with exposure to permethrin at concentrations above 10 percent (%). The APSS assistant recommended the owner call back with questions.
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. A follow up was not performed, because additional information was not expected (the cat was nearly recovered).
