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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-1753

2. Registrant Information.

Registrant Reference Number: US2008-00360

Registrant Name (Full Legal Name no abbreviations): Schering-Plough Animal Health Canada

Address: 3535 Trans-Canada

City: Pointe Claire

Prov / State: Quebec

Country: Canada

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

04-MAR-08

5. Location of incident.

Country: UNITED STATES

Prov / State: SOUTH DAKOTA

6. Date incident was first observed.

31-JAN-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. 773-84

Product Name: Ultra Boss Pour-On 6x1gal

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration 5 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

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).

30 ml was applied and one week later 30 ml was applied again

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

Medical Professional

2. Type of animal affected

Horse / Cheval

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

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?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Death

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Efficacy On March 4, 2008 a veterinary technician reported a possible lack of efficacy regarding a horse that died following treatment with Ultra Boss. Technician reported an end user in (state) , Owner, purchased Ultra Boss (60911B) on January 31, 2008 to treat his horse for severe tick infestation. Within a day or two of purchase the owner reported 30 ml was administered to the horse. 7 days later the horse remained infested with ticks so Ultra Boss was administered again. The owner reported to technicianr that the horse was found dead on February 26, 2008. Owner believed the horse died from severe tick infestation because the Ultra Boss failed to control the horse's ticks. A necropsy was not performed nor was the horse examined by a veterinarian. No more information is required.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here