Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-1222
2. Registrant Information.
Registrant Reference Number: 2382
Registrant Name (Full Legal Name no abbreviations): Virbac Animal Health
Address: 3200 Meacham Blvd.
City: Ft. Worth
Prov / State: Texas
Country: United States
Postal Code: 76137
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
02-OCT-09
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
02-OCT-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. 22919
PMRA Submission No.
EPA Registration No. 2382-117
Product Name: Ecto-Soothe 3X Emollient Oatmeal Pesticidal Shampoo
- Active Ingredient(s)
- PIPERONYL BUTOXIDE
- PYRETHRINS
7. b) Type of formulation.
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 10/02/09 Sponsor was contacted by (name) to report an apparent adverse reaction to Ecto-Sootheż 3X Emollient Oatmeal Pesticidal Shampoo. According to report the animal owner bathed dog at 10:30 PM on 10/2/09. According to animal owner while bathing he accidentally got some drug product in the dog's eyes. According to report within unspecified amount of time the dog began rubbing face and experienced bloodshot eyes. No further information available. Outcome unknown.
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
Other
2. Type of animal affected
Dog / Chien
3. Breed
Shih Tzu
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 )
6.30
lbs
8. Route(s) of exposure
Eye
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Unknown/Inconnu
16. How was the animal exposed?
Other / Autre
specify accidental
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here