Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-5544
2. Registrant Information.
Registrant Reference Number: 100091300
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.
14-JUL-10
5. Location of incident.
Country: UNITED STATES
Prov / State: OHIO
6. Date incident was first observed.
14-JUL-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.
PMRA Submission No.
EPA Registration No. 2724-504
Product Name: Zodiac Spot On Plus Flea and Tick Control for Cats Greater Than 5 Lbs
- 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
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 July 13, 2010 the owner applied the product onto the under labelled under aged 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 Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.1538
7. Weight (provide a range if necessary )
1
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Lethargy
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
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 July 14, 2010 the APSS veterinarian stated the product was used off label use and there is risk of hypoglycemia as a result of the anorexia, and the kitten may also be anemic from fleas (as the product was being used to treat rather than prevent). The APSS technician relayed the APSS veterinarian's recommendations to take the kitten to the veterinarian, having the veterinarian call for information, and calling back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
On July 16, 2010 an APSS assistant called the owner to follow up the case. The owner stated she had taken the kitten to veterinarian, but the kitten died on the table. This product was not used according to label directions: do not use on kittens under 12 weeks of age.