Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3367

2. Registrant Information.

Registrant Reference Number: US2008-01510

Registrant Name (Full Legal Name no abbreviations): Schering-Plough Canada Inc.

Address: 16750, Route Transcanadienne

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

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

Human

4. Date registrant was first informed of the incident.

15-JUL-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

07-JUL-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 773-59

Product Name: Atroban 11%EC

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Medical Professional

2. Demographic information of data subject

Sex: Male

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Burns (2nd or 3rd degree)
  • Symptom - Inflammation of the skin

4. How long did the symptoms last?

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

5. Was medical treatment provided? Provide details in question 13.

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Occupational

8. How did exposure occur? (Select all that apply)

Application

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

Unknown

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Human Exposure/ Adverse Event- Rocky Mountain Poison and Drug Center reported that a nurse from a Hospital reported that a patient,, was out spraying his cattle when his ATV rolled on approximately 7/7/08. The tank of Atroban 11% poured on him and he laid in the Atroban for 4 hours. He has dermal exposure and chemical burns to his upper body. On July 13, 2008 he started having swelling in the jaw area. The size of his face has doubled during the night. RMPDC reported that it is unlikely that the swelling that occurred 6 days post exposure is directly related to the product and that they should check with the MD. SPAH Veterinarian, reported that he spoke to the Hospital on July 17, 2008. They reported that the patient is still in the hospital in progressive care. He was moved over the weekend from ICU and has serious chemical burns and other injuries related to his accident. On July 21, 2008, SPAH Veterinarian followed up with the progressive care nurse. She reported that the patient sustained a fractured pelvis and other physical injuries in the accident as well as chemical exposure burns to his thorax, primarily his back. The nurse stated that the chemical burns were healing or healed and were not the patients major issues in his recovery. No further follow up required.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Human Exposure/ Adverse Event- Rocky Mountain Poison and Drug Center reported that a nurse from a Hospital reported that a patient,, was out spraying his cattle when his ATV rolled on approximately 7/7/08. The tank of Atroban 11% poured on him and he laid in the Atroban for 4 hours. He has dermal exposure and chemical burns to his upper body. On July 13, 2008 he started having swelling in the jaw area. The size of his face has doubled during the night. RMPDC reported that it is unlikely that the swelling that occurred 6 days post exposure is directly related to the product and that they should check with the MD. SPAH Veterinarian, reported that he spoke to the Hospital on July 17, 2008. They reported that the patient is still in the hospital in progressive care. He was moved over the weekend from ICU and has serious chemical burns and other injuries related to his accident. On July 21, 2008, SPAH Veterinarian followed up with the progressive care nurse. She reported that the patient sustained a fractured pelvis and other physical injuries in the accident as well as chemical exposure burns to his thorax, primarily his back. The nurse stated that the chemical burns were healing or healed and were not the patients major issues in his recovery. No further follow up required.