Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-5017
2. Registrant Information.
Registrant Reference Number: 090104911
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.
17-SEP-09
5. Location of incident.
Country: UNITED STATES
Prov / State: ILLINOIS
6. Date incident was first observed.
17-SEP-09
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 for Cats and Kittens
- 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.
.33
Other Units: tube
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 13, 2009 the owner inappropriately applied 1/3 of the product from the tube onto the underaged kitten to treat a flea infestation.
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 Medium Hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.13
7. Weight (provide a range if necessary )
3.0
lbs
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
- Nervous and Muscular Systems
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
The APSS veterinarian stated that the age of the kitten was too young for use of the product and may increase the likelihood of neurologic effects. Based on the reported history and signs, she suspects the kitten had a severe flea anemia. She recommended that the owner take the kitten to the veterinarian and have the veterinarian call for recommendations on this case.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS technician stated that the substance was considered to have a low likelihood of causing the clinical situation. The owner reported that the kitten died on the way to the veterinarian on September 17, 2009 after the APSS consultation. This product was not used according to label directions: do not use on kittens under 12 weeks of age.