Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-4455
2. Registrant Information.
Registrant Reference Number: 100105855
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.
13-AUG-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
11-AUG-10
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.
2
Other Units: drops
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 8, 2010 the owner inappropriately applied the product onto the kitten.
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
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.269
7. Weight (provide a range if necessary )
4
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- General
- Symptom - Weakness
- Symptom - Lethargy
- Renal System
- Symptom - Urinary incontinence
- Gastrointestinal System
- Symptom - Fecal incontinence
12. How long did the symptoms last?
Persisted until death
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
Died
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 11, 2010 the kitten became symptomatic. On August 12, 2010 the kitten became lethargic, weak, and had urinary and fecal incontinence, so later that day the owner bathed the kitten twice with an unknown flea and tick shampoo. On August 13, 2010 the owner found the kitten dead. Later that day, the owner contacted the Animal Product Safety Service (APSS). The APSS assistant relayed the APSS veterinarian's recommendations to contact his regular veterinarian to have a necropsy done, call back with questions, and call the manufacturer for reimbursement questions. The owner declined the necropsy as the pet had already been buried.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
A follow up was not performed, because additional information was not expected. This product was not used according to label directions. According to the specialsiss at APSS, use of the product was not related to the clinical signs.