Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-5686
2. Registrant Information.
Registrant Reference Number: 1-26396887
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.
06-JUN-11
5. Location of incident.
Country: UNITED STATES
Prov / State: KENTUCKY
6. Date incident was first observed.
03-JUN-11
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/L
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 June 3rd, 2011 product was applied to multiple cats.
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 Long hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
7
7. Weight (provide a range if necessary )
22
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Eye
- Symptom - Other
- Specify - Wild eyes
- Gastrointestinal System
- Symptom - Salivating excessively
- Specify - salivation
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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 June 3rd 2011 cat became symptomatic after product was applied. Caller contacted DVM who told her to bathe the cat with Dawn. This was done and cat seemed to be better but was lethargic. Saturday morning June 4th symptoms continued.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
On June 5th, 2011 cat passed away. This is not an expected effect when product is used according to label direction. Cat was already buried unable to perform necropsy.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Mixed breed
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
13
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 - Abnormal behaviour
- Specify - sitting in one spot
- Nervous and Muscular Systems
- Symptom - Muscle tremors
- Specify - tremor
12. How long did the symptoms last?
Unknown / Inconnu
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
Product was applied to cat on June 3rd, 2011. Caller said he became symptomatic shortly after product was applied but showed signs of improvement. On June 10th, 2011 the cat became symptomatic and later died.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Necropsy could not be performed as cat had already been buried. The product was not used according to label directions. Label states "consult a veterinarian before using on aged animals" and if signs of sensitivity occur, bathe your pet with mild soap and rinse with large amounts of water. If signs continue consult a veterinarian immediately.