Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-1422
2. Registrant Information.
Registrant Reference Number: 2012CA00299
Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)
Address: 16750 Transcanada Highway
City: Kirkland
Prov / State: Quebec
Country: Canada
Postal Code: H9H 4M7
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
28-MAR-12
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
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. 25488
PMRA Submission No.
EPA Registration No.
Product Name: Boss Pour On
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
30
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).
Adverse event reaction reported by the clinic. 5 adult horses were treated with Boss Pour On for the treatment of lice along the dorsal mid-line. The lice were visibly seen on the horses. All of the horses' developed some irritation at the site of application with hair loss. The clinic concedes they have recommended off label use of Boss Pour On in equines. They have reportedly used the product before successfully wit no reactions. Outcome, the horse has recovered, the case is resolved. This case is linked to case # . Case closed
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
Medical Professional
2. Type of animal affected
Horse / Cheval
3. Breed
unknown
4. Number of animals affected
5
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Irritated skin
- Symptom - Hair loss
12. How long did the symptoms last?
>1 mo and <= 2mos / >1 mois et < = 2mois
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
No
14. b) How long was the animal hospitalized?
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
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here