Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-2599
2. Registrant Information.
Registrant Reference Number: 090067288
Registrant Name (Full Legal Name no abbreviations): Wellmark International
Address: 100 Stone Road West, Suite 111
City: Guelph
Prov / State: Ontario
Country: Canada
Postal Code: N1G5L3
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
18-JUN-09
5. Location of incident.
Country: UNITED STATES
Prov / State: GEORGIA
6. Date incident was first observed.
07-JUN-09
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. 2724-404-270
Product Name: Bio Spot Flea and Tick Spray for Cats and Kittens
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .27 %
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- Guarantee/concentration .62 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration .37 %
- PYRETHRINS
- Guarantee/concentration .2 %
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 June 4, 2009, the owner applied the product to her cats to treat a flea infestation.
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
Himalayan
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5.5
7. Weight (provide a range if necessary )
9
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- General
- Symptom - Adipsia
- Symptom - Lethargy
- Liver
- Symptom - Hepatic failure
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 June 8, 2009, the owner took the cat to the veterinarian who diagnosed the cat with acute renal and hepatic failure based on physical exam findings. The cat died in the clinic that same day. The APSS veterinarian stated that this product is not expected to cause renal or hepatic failure. A necropsy was not recommended because the body was no longer available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
9.5
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
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- General
- Symptom - Adipsia
- Symptom - Lethargy
- Liver
- Symptom - Hepatic failure
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 June 8, 2009, the owner took the cat to the veterinarian who diagnosed the cat with acute renal and hepatic failure based on physical exam findings. On June 11, 2009, the cat died at home. The APSS veterinarian stated that this product is not expected to cause renal or hepatic failure. A necropsy was not recommended because the body was no longer available.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.