Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-4975

2. Registrant Information.

Registrant Reference Number: 2015-US-10963

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.

02-SEP-15

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

22-AUG-15

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
    • Guarantee/concentration 5 %

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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).

SLEE: On 2 Sept 2015, a producer reported that he weaned around 550 spring born calves weighing around 650 pounds between 8 Aug 2015 and 18 Aug 2015. The calves were vaccinated with Vista Once, Cavalry 9, treated with Safeguard 10% Suspension, poured with Ultra Saber and implanted with Revalor G at that time. 12-15 days after weaning, they had some respiratory pulls and have pulled and treated 31 head with 3 ml / 100 pounds Baytril for 3 days in a row. 6 head have died-no necropsies or diagnostic work has been done. The calves had been vaccinated in the spring with ViraShield 6 and Covexin 8. No further follow up expected.

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

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Angus Beef Cattle

4. Number of animals affected

25

5. Sex

Unknown

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

650

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

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

11. List all symptoms

System

• Respiratory System
  • Symptom - Other
  • Specify - respiratory signs

12. How long did the symptoms last?

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

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

Yes

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

6 died, 25 under treatment . 3 ml / 100 pounds of Baytril for 3 days in a row.

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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

Nothing to add.

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cow / Vache

3. Breed

Angus Beef Cattle

4. Number of animals affected

6

5. Sex

Unknown

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

650

lbs

Unknown

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

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

11. List all symptoms

System

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Other
  • Specify - Respiratory signs

12. How long did the symptoms last?

Persisted until death

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

Yes

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

6 died, 25 under treatment . 3 ml / 100 pounds of Baytril for 3 days in a row.

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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

Nothing to add.