Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2009-0542
2. Registrant Information.
Registrant Reference Number: 080124425
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.
06-NOV-08
5. Location of incident.
Country: UNITED STATES
Prov / State: MICHIGAN
6. Date incident was first observed.
02-NOV-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. 2724-504-270
Product Name: Bio Spot Spot On Flea and Tick Control 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.
.061
Units: oz (fl) / oz (liquide)
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 November 1, 2008, the owner applied the product to her 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 Shorthair Cat
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
7.4
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Trembling
- Symptom - Seizure
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
Unknown
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 November 2, the owner took her two cats to the veterinarian. The veterinarian provided care in the form of managing both the seizures and tremors. The APSS veterinarian stated significant neurologic signs are not expected with the appropriate use of etofenprox in cats. Two dogs were treated with a permethrin product. Signs are consistent with a permethrin exposure. The APSS veterinarian recommended necropsies be performed, but the bodies were 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
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair Cat
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2
7. Weight (provide a range if necessary )
7.5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Seizure
- Symptom - Trembling
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
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 November 2, the owner took her two cats to the veterinarian. The veterinarian provided care in the form of managing both the seizures and tremors. The APSS veterinarian stated significant neurologic signs are not expected with the appropriate use of etofenprox in cats. Two dogs were treated with a permethrin product. Signs are consistent with a permethrin exposure. The APSS veterinarian recommended necropsies be performed, but the bodies were 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