Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1127
2. Registrant Information.
Registrant Reference Number: 070104996
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.
04-OCT-07
5. Location of incident.
Country: UNITED STATES
Prov / State: NEW JERSEY
6. Date incident was first observed.
26-SEP-07
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.
PMRA Submission No.
EPA Registration No. 2724-504
Product Name: Zodiac Spot On Plus Flea And Tick Control Cats 5 lbs And Over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 40 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.8
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 September 22, 2007 +/- 2 days, the owner applied the product to her cat as a form of treatment.
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 )
11
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
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
- Gastrointestinal System
- Symptom - Other
- Specify - Increase in appetite
- General
- Symptom - Weakness
- Symptom - Death
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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 October 4, 2007 the APSS veterinary technician stated that product usage may lead to self limiting, dermal hypersensitivity. Signs of polyphagia, weakness, and especially death would not be expected with an exposure to this product. The APSS staff member suggested a necropsy be performed on the animal.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS staff member doubted that use of this product led to the clinical situation.