Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-5576
2. Registrant Information.
Registrant Reference Number: 100125179
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.
24-SEP-10
5. Location of incident.
Country: UNITED STATES
Prov / State: CALIFORNIA
6. Date incident was first observed.
24-SEP-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. 29909-2-2724
Product Name: Zodiac Fleatrol Flea and Tick Shampoo for Dogs and Cats
- Active Ingredient(s)
- PIPERONYL BUTOXIDE
- Guarantee/concentration .5 %
- PYRETHRINS
- Guarantee/concentration .05 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 24, 2010 the owner bathed the cat with the product.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
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 )
3
7. Weight (provide a range if necessary )
10
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Vocalizing
- Symptom - Death
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 September 24, 2010 the cat became symptomatic shortly after the bath. The cat then died a few minutes later. The owner then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated this shampoo contains pyrethrins in a low concentration. The APSS veterinarian discussed ruling out hypertrophic cardiomyopathy (HCM) and recommended a necropsy. The APSS veterinarian recommended the owner take the cat's body to the veterinarian, have the veterinarian call for information on the necropsy.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
On October 5, 2010 the final necropsy results were received from the U of I. The necropsy results stated the most significant changes are the gross and histologic evidence of cardiomyopathy which most likely resulted in death of this animal, not a toxin from the shampoo.