Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-5693
2. Registrant Information.
Registrant Reference Number: 1-263251
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.
25-MAY-11
5. Location of incident.
Country: UNITED STATES
Prov / State: MARYLAND
6. Date incident was first observed.
Unknown
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
- 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.
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).
Product was applied to cats on May 17th, 2011.
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
not known
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
29
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Renal System
- Symptom - Other
- Specify - unable to urinate
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
Product was applied on May 17th, 2011. Cats became symptomatic however date this was observed is unknown. Cat died on May 22nd, 2011.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
There is little information provided, owner suspected kidney failure but did not seek veterinary care. The cat was buried therefore necropsy was not performed. It is unknown exactly which product was used as package was thrown away therefore unclear if proper dosage or product was used. A necropsy can not be performed therefore it is not possible to determine cause of symptoms and death. Per company veterinarian, product was determined doubtfully related.
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 )
3
7. Weight (provide a range if necessary )
11
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Renal System
- Symptom - Other
- Specify - unable to urinate
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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 on May 17th, 2011. Cats became symptomatic however date this was observed is unknown. Cat died on May 22nd, 2011.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
There is little information provided, owner suspected kidney failure but did not seek veterinary care. The cat was buried therefore necropsy was not performed. It is unknown exactly which product was used as package was thrown away therefore unclear if proper dosage or product was used. A necropsy can not be performed therefore it is not possible to determine cause of symptoms or death. Per company veterinarian, product was determined doubtfully related.