Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-4865

2. Registrant Information.

Registrant Reference Number: US2008-02138

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

Address: 16750 Trans Canada Hwy.

City: Kirkland

Prov / State: QC

Country: Canada

Postal Code: H9H4M7

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

Human

4. Date registrant was first informed of the incident.

22-SEP-08

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

22-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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 773-84

Product Name: ULTRA BOSS POUR ON 6XGA

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

---

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).

The farmer was rubbing Ultra Boss on animals and not washing his/her hands afterwards for the last 2 months, without changing clothing after application.

To be determined by Registrant

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

No

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: >12 <=19 yrs / >12 <=19 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Bloody diarrhea

• Skin
  • Symptom - Jaundice

• Liver
  • Symptom - Enlargement of the liver

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Weight loss
  • Symptom - Other
  • Specify - severe intestinal bleeding

4. How long did the symptoms last?

Unknown / Inconnu

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

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

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

12. Time between exposure and onset of symptoms.

>1 mo <=2 mos / > 1 mois < = 2 mois

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. Poison Drug Center reported that a Chiropractor caring for a patient that had been rubbing Ultra Boss on animals and not washing his hands afterwards for the last 2 months. Also he had not been changing his clothing afterwards. The doctor reported that the patient's bowels are not functioning and his liver is swollen on exam but not on CT scan. His skin is showing a yellow color and his symptoms were worsening. He sent the patient to a PA who did blood work revealing a virus. An MD reported that the patient is lethargic, losing weight, turning yellow and CT scan showed cholecystitis. Poison control reported to the two doctors that permethrin is not well absorbed into the skin and that the patient's symptoms are not consistent with permethrin exposure. They have now put the patient on fluids due to diarrhea. A SPAH Veterinarian, reported that he spoke to the doctor on 9/24/08.He reported that the patient is in the hospital in (city,state) He still has severe intestinal bleeding and the hospital has a colon scope planned. They have found no bacteria, no parasites and have done no toxicity. The hospital does not seem concerned that the problem is due to long term exposure to Ultra Boss. Follow up pending.They have found no bacteria, no parasites and have done no toxicity. The hospital does not seem concerned that the problem is due to long term exposure to Ultra Boss. Follow up pending.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.