Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-0956
2. Registrant Information.
Registrant Reference Number: 110105786
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.
16-AUG-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
01-AUG-11
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. 21744
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Endalsect Flea Spray For Dogs and Cats
- Active Ingredient(s)
- (S)-METHOPRENE
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- PIPERONYL BUTOXIDE
- PYRETHRINS
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 August 1, 2011 the owner applied the spray to 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
Siamese Mix
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3.0
7. Weight (provide a range if necessary )
12.5
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
12. How long did the symptoms last?
<=30 min / <=30 min
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
On August 1, 2011 the owner noticed that the cat started drooling about 5 minutes after she had been sprayed with the product. Per the owner, this was an isolated event. On August 16, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that cats may have hypersalivation from the smell or taste of the product, which is self-limiting. The APSS veterinarian also stated that occasionally animals may have mild dermal irritation, pruritus, or hyperesthesia from dermal exposures to the product. The APSS assistant recommended that the owner monitor the cat at home, call back with questions, and decontaminate the environment. The owner also learned about the mechanism of dog spot on products during the call to APSS.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a high likelihood of causing the clinical situation. A follow up was not performed, because signs were expected to be mild and self-limiting.