Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-5659
2. Registrant Information.
Registrant Reference Number: 08-1-16195111
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.
27-MAY-08
5. Location of incident.
Country: UNITED STATES
Prov / State: FLORIDA
6. Date incident was first observed.
26-MAY-08
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. 2724-504-2596
Product Name: HARTZ ULTRAGUARD PRO FLEA AND TICK DROPS FOR CATS 5 LBS AND OVER
- 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.
1.8
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).
Owner applied product to her cat on May 27, 2008.
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 )
2
7. Weight (provide a range if necessary )
10.50
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
On May 27, 2008, A PROSAR representative advised the owner the product has a wide margin of safety and low level of toxicity when used according to the labeled directions. Sudden death is atypical and unexpected. Necropsy was offered but the animal had already been buried.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
A PROSAR representative stated the reason for sudden death in a young cat can include infectious disease and congenital issues such as cardiac disease. They further stated that the product is very safe and highly unlikely to be the cause of sudden death in a young cat.