Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-4533

2. Registrant Information.

Registrant Reference Number: 2012-US-06128

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

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

Domestic Animal

4. Date registrant was first informed of the incident.

06-SEP-12

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

04-SEP-12

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. 773-92

Product Name: Ultra Saber Pour On

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN
    • Guarantee/concentration 1 %
  • PIPERONYL BUTOXIDE

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Pyramid Presponse

• Active Ingredient(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Safeguard Drench

• Active Ingredient(s)

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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).

Lack of Efficacy. On 6 September 2012 a producer reported that Zuprevo did not work. On arrival the producer gave 82 calves Pyramid Presponse, Safeguard drench and pours with Ultra Saber, he also used Zuprevo on 82 head, 21 showed signs of respiratory distress and 5 died. Diagnostic work pending. Follow-up on 27 September 2012: Lab Resluts show Mannheimia Haemolytica. The case is closed.

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

Cow / Vache

3. Breed

Angus

4. Number of animals affected

21

5. Sex

Unknown

6. Age (provide a range if necessary )

0.25

7. Weight (provide a range if necessary )

500

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Respiratory distress

• General
  • Symptom - Death
  • Symptom - Parasitism
  • Specify - Mannheimia Haemolytica

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

14. a) Was the animal hospitalized?

Unknown

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

82 cows were treated in total, 21 reacted, 5 died, 16 unknown.

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To be determined by Registrant

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

Death

19. Provide supplemental information here