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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0609

2. Registrant Information.

Registrant Reference Number: US2007-01441

Registrant Name (Full Legal Name no abbreviations): SCHERING-PLOUGH ANIMAL HEALTH CANADA

Address: 3535 TRANS-CANADA

City: POINTE-CLAIRE

Prov / State: H9R-1B4

Country: CANADA

Postal Code: H9R-1B4

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

Domestic Animal

4. Date registrant was first informed of the incident.

18-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: NEBRASKA

6. Date incident was first observed.

15-JUN-07

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.

Product Name: ATROBAN EC 11%

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration 11 %

7. b) Type of formulation.

Liquid

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).

Adverse Event- Dr (name), SPAH veterinarian, spoke with Dr.(name)concerning Atroban and possible cattle deaths on June 15, 2007. Dr. (name) had determined that although the cattle had been sprayed with Atroban, the underlying cause of death was organo-phosphate toxicity due to not properly cleaning out the sprayer that had been previously used for Diazinon, before mixing Atroban 11%. 11 head of 1200 pound steers, approximately two weeks from slaughter, were sprayed and all 11 died. Based on clinical symptoms described by the owner, Dr. (name) suspected OP toxicity and upon further questioning determined that the sprayer had not been properly cleaned. The producer had the renderer pick up the animals before any diagnostics could be performed. No further follow up required.

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

Cow / Vache

3. Breed

Cattle

4. Number of animals affected

11

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

1200

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

  • Nervous and Muscular Systems
    • Symptom - Trembling
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Death

12. How long did the symptoms last?

>8 hrs <=24 hrs / > 8 h < = 24 h

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

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

Adverse Event- Dr (name), SPAH veterinarian, spoke with Dr. (name) concerning Atroban and possible cattle deaths on June 15, 2007. Dr. (name) had determined that although the cattle had been sprayed with Atroban, the underlying cause of death was organo-phosphate toxicity due to not properly cleaning out the sprayer that had been previously used for Diazinon, before mixing Atroban 11%. 11 head of 1200 pound steers, approximately two weeks from slaughter, were sprayed and all 11 died. Based on clinical symptoms described by the owner, Dr. (name) suspected OP toxicity and upon further questioning determined that the sprayer had not been properly cleaned. The producer had the renderer pick up the animals before any diagnostics could be performed. No further follow up required.


To be determined by Registrant

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

Death

19. Provide supplemental information here