Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2007-8881
2. Registrant Information.
Registrant Reference Number: 070083394
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: ON
Country: Canada
Postal Code: N1G 5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
07-AUG-07
5. Location of incident.
Country: UNITED STATES
Prov / State: MAINE
6. Date incident was first observed.
06-AUG-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. 2990922724
Product Name: Zodiac Fleatrol Flea And Tick Shampoo For Dogs and Cats2990922724
- 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 August 6, 2007 at 6:00 PM CDT, the owner bathed the kitten with the product.
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 )
0.42
7. Weight (provide a range if necessary )
3.5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
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
Prior to application of product on August 6, 2007, the owner stated that the cat had chronic nasal discharge and crustiness by her nostrils. The owner also stated that they had been camping for five days prior to the exposure, and it is possible that the cat got into something while not being supervised. Necropsy Results: Bone marrow hyperplasia is suspected secondary to chronic anemia from parasitism. The pathologist suspected a cardiac arrhythmia, secondary to severe anemia, was the proximate cause of death.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
APSS stated that the signs were not consistent with the use of the shampoo, and that the worst anticipated outcome might be a bad taste reaction. The APSS staff therefore determined that this product was not related to causing the clinical situation. The pathologist suspected a cardiac arrhythmia, secondary to severe anemia, was the proximate cause of death.