Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-0056

2. Registrant Information.

Registrant Reference Number: 2018-CA-03742

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

Address: 6750 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.

13-DEC-18

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

Unknown

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. 27829      PMRA Submission No.       EPA Registration No. 773-74

Product Name: Saber Pour On

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN

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7. b) Type of formulation.

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).

Suspected adverse reaction reported by the herd vet on 13 Dec 2018. A Holstein dairy operation with 400 dairy calves, roughly one week old, received Bovilis Ringvac (imported product) and Saber Pour On on 07 Dec 2018. Approximately 300 dairy calves showed discomfort( kicking, ears and head down) and itching for a few days, this resolved after 3-4 days. Nothing further is 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

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Holstein

4. Number of animals affected

300

5. Sex

Female

6. Age (provide a range if necessary )

0.02

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Discomfort

• Skin
  • Symptom - Pruritus

• Nervous and Muscular Systems
  • Symptom - Abnormal posture
  • Specify - abnormal posture head and ears down

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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

Fully Recovered / Complètement 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

Suspected adverse reaction reported by the herd vet on 13 Dec 2018. A Holstein dairy operation with 400 dairy calves, roughly one week old, received Bovilis Ringvac (imported product) and Saber Pour On on 07 Dec 2018. Approximately 300 dairy calves showed discomfort( kicking, ears and head down) and itching for a few days, this resolved after 3-4 days. Nothing further is expected.

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To be determined by Registrant

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

Minor

19. Provide supplemental information here