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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-0604

2. Registrant Information.

Registrant Reference Number: US2007-01472

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

Address: 3535 Trans-Canada

City: Pointe-Claire

Prov / State: Quebec

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.

22-JUN-07

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

03-MAY-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: Ultra Boss Pour-On Insecticide

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

25

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).

25ml; Topical

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

1

5. Sex

Unknown

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Hair loss

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Adverse Event- Dr. (name), SPAH veterinarian, reported that (name), reported the death of a bull 2-3 days after treatment with Ultra boss pour-on. This bull was treated along with approximately 200 other animals in late April or early May. He was the first animal down the chute to be treated at 9 a.m. He was not noticed as being abnormal from the time of treatment till turnout, approximately 2 hours later. The bull walked back to the pasture and was found dead by a field worker 3 days later. He was 1 mile from the working (name). A hairless strip was noticed from shoulders to hips down the midline. The carcass was autolyzed to the point that a necropsy was not feasible. Other treated cows were noted to have standing hair and discoloration in the area of application. Follow up Dr. (name) will contact a local veterinarian, Dr.(name), to consult with Mr. (name) and examine affected cattle. 9/28/07 Dr. (name)visited the (name) ranch and examined affected cows. Some were observed to have some discoloration of the skin in the area along the dorsal midline. One skin biopsy was collected and submitted to a diagnostic lab for evaluation. 11/17/07 A lab reported was faxed to Dr. (name) from Dr. (name) office. It indicated there were subtle skin changes, classified as 'minimal eosinophilic mastocytic dermatitis'. 11/22/07 Dr. (name) discussed the lab report and Dr. (name) findings with Mr. (name). No definite association of Ultra Boss treatment and the symptoms observed in the cattle could be made. Mr. (name) added, that in addition to the death of the bull, he felt Schering Plough was responsible for 4 abortions. He had 4 cows that were diagnosed as pregnant prior to treatment, and were now open. (Dr. (name) was unaware of any abortions. They had not been discussed during his visit).


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

196

5. Sex

Unknown

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Discolouration

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Unknown/Inconnu

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, reported that (name), reported the death of a bull 2-3 days after treatment with Ultra boss pour-on. This bull was treated along with approximately 200 other animals in late April or early May. He was the first animal down the chute to be treated at 9 a.m. He was not noticed as being abnormal from the time of treatment till turnout, approximately 2 hours later. The bull walked back to the pasture and was found dead by a field worker 3 days later. He was 1 mile from the working (name). A hairless strip was noticed from shoulders to hips down the midline. The carcass was autolyzed to the point that a necropsy was not feasible. Other treated cows were noted to have standing hair and discoloration in the area of application. Follow up Dr. (name) will contact a local veterinarian, Dr.(name), to consult with Mr. (name) and examine affected cattle. 9/28/07 Dr. (name)visited the (name) ranch and examined affected cows. Some were observed to have some discoloration of the skin in the area along the dorsal midline. One skin biopsy was collected and submitted to a diagnostic lab for evaluation. 11/17/07 A lab reported was faxed to Dr. (name) from Dr. (name) office. It indicated there were subtle skin changes, classified as 'minimal eosinophilic mastocytic dermatitis'. 11/22/07 Dr. (name) discussed the lab report and Dr. (name) findings with Mr. (name). No definite association of Ultra Boss treatment and the symptoms observed in the cattle could be made. Mr. (name) added, that in addition to the death of the bull, he felt Schering Plough was responsible for 4 abortions. He had 4 cows that were diagnosed as pregnant prior to treatment, and were now open. (Dr. (name) was unaware of any abortions. They had not been discussed during his visit).


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

4

5. Sex

Unknown

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Reproductive System
    • Symptom - Spontaneous abortion

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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

Not recovered / Non 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

Adverse Event- Dr. (name), SPAH veterinarian, reported that (name), reported the death of a bull 2-3 days after treatment with Ultra boss pour-on. This bull was treated along with approximately 200 other animals in late April or early May. He was the first animal down the chute to be treated at 9 a.m. He was not noticed as being abnormal from the time of treatment till turnout, approximately 2 hours later. The bull walked back to the pasture and was found dead by a field worker 3 days later. He was 1 mile from the working (name). A hairless strip was noticed from shoulders to hips down the midline. The carcass was autolyzed to the point that a necropsy was not feasible. Other treated cows were noted to have standing hair and discoloration in the area of application. Follow up Dr. (name) will contact a local veterinarian, Dr.(name), to consult with Mr. (name) and examine affected cattle. 9/28/07 Dr. (name)visited the (name) ranch and examined affected cows. Some were observed to have some discoloration of the skin in the area along the dorsal midline. One skin biopsy was collected and submitted to a diagnostic lab for evaluation. 11/17/07 A lab reported was faxed to Dr. (name) from Dr. (name) office. It indicated there were subtle skin changes, classified as 'minimal eosinophilic mastocytic dermatitis'. 11/22/07 Dr. (name) discussed the lab report and Dr. (name) findings with Mr. (name). No definite association of Ultra Boss treatment and the symptoms observed in the cattle could be made. Mr. (name) added, that in addition to the death of the bull, he felt Schering Plough was responsible for 4 abortions. He had 4 cows that were diagnosed as pregnant prior to treatment, and were now open. (Dr. (name) was unaware of any abortions. They had not been discussed during his visit).


To be determined by Registrant

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

Death

19. Provide supplemental information here