Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-7146
2. Registrant Information.
Registrant Reference Number: 120165913
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.
30-NOV-12
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
30-NOV-12
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 November 30, 2012 the owner applied the product to 2 cats to treat for fleas. The owner believed that the cats were able to groom the product off of themselves.
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 )
0.25
7. Weight (provide a range if necessary )
4.0
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
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Drooling
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 November 30, 2012 the owner noticed that the cat was symptomatic. The owner immediately contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal hypersensitivity can be seen with topical flea products, and it is likely that this is more from the carriers than from the active ingredients. The APSS veterinarian said that with an oral exposure, a taste reaction could be seen. The APSS veterinarian stated that signs are generally self-limiting. The APSS assistant recommended that the owner give nothing to the cat by mouth for one hour, give the cat a taste treat to remove the bad taste, and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs are 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
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
4.0
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
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Drooling
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
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 November 30, 2012 the owner noticed that the cat was symptomatic. The owner immediately contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that dermal hypersensitivity can be seen with topical flea products, and it is likely that this is more from the carriers than from the active ingredients. The APSS veterinarian said that with an oral exposure, a taste reaction could be seen. The APSS veterinarian stated that signs are generally self-limiting. The APSS assistant recommended that the owner give nothing to the cat by mouth for one hour, give the cat a taste treat to remove the bad taste, and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs are expected to be mild and self limiting.