Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-5803
2. Registrant Information.
Registrant Reference Number: 080047061
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.
05-MAY-08
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
05-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. 26495
PMRA Submission No.
EPA Registration No.
Product Name: Vet Kem Ovi Spot Plus Flea And Tick Control For Dogs Over 14 Kgs
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
2
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).
On May 4, 2008, the owner's grandmother applied the product to the cat as a preventative measure.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
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
Male
6. Age (provide a range if necessary )
0.58
7. Weight (provide a range if necessary )
16
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
- General
- Symptom - Vocalizing
- Symptom - Hyperactivity
- Nervous and Muscular Systems
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.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
1
Day(s) / Jour(s)
15. Outcome of the incident
Fully Recovered / Complètement rétabli
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 5, 2008, the APSS veterinarian recommended that the owner take the cat to thier local veterinarian. On the same day, the owner's veterinarian contacted the APSS. The APSS veterinarian recommended that the cat be hospitalized on IV fluids and given a bath. The APSS veterinarian also recommended that Vitamin E be applied to the application site and that the attending veterinarian call the APSS with any further questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The attending veterinarian reported that the cat's signs ended with treatment on May 6, 2008. This product was not used according to label directions. Dog product used on cat.