Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-5892
2. Registrant Information.
Registrant Reference Number: 1-37831685
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.
17-JUL-14
5. Location of incident.
Country: UNITED STATES
Prov / State: MICHIGAN
6. Date incident was first observed.
12-JUL-14
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. 2724-401-2596
Product Name: Hartz UltraGuard Plus Flea and Tick Home Spray
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .01 %
- PERMETHRIN
- Guarantee/concentration .28 %
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 July 11, 2014 caller inappropriately applied home product to kittens.
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
Unknown
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
.27
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
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.
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 unknown date caller gave the kitten a flea bath then on July 11, 2014, caller used premise product on kitten and it became symptomatic. On July 16, 2014, kitten died. No veterinary care was sought.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Off Label Use: product not labelled for use on animals. The staff veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.