Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-0107
2. Registrant Information.
Registrant Reference Number: 110111372
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.
29-AUG-11
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
26-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. 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 26, 2011 the owner applied the product to the neck and tail area on 3 of her cats.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
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
2
5. Sex
Female
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
12.0
lbs
8. Route(s) of exposure
Skin
Oral
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 26, 2011, just after she applied the product to her cats, the owner noticed they were drooling. The drooling ended within 10 minutes. On August 29, 2011 the owner contacted the company to obtain help. The company's veterinarian stated that if the product was ingested via grooming, a taste reaction characterized by hypersalivation could occur. The company's veterinarian also stated that the taste reaction could be resolved by feeding a taste treat to replace the bad taste.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs expected to be mild and self limiting.
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
Female
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
9.0
lbs
8. Route(s) of exposure
Skin
Oral
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 26, 2011, just after she applied the product to her cat, the owner noticed she was drooling. The drooling ended within 10 minutes. On August 29, 2011 the owner contacted the company to obtain help. The company's veterinarian stated that if the product was ingested via grooming, a taste reaction characterized by hypersalivation could occur. The company's veterinarian also stated that the taste reaction could be resolved by feeding a taste treat to replace the bad taste.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs expected to be mild and self limiting.