Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3436

2. Registrant Information.

Registrant Reference Number: 2016-US-08180

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.

31-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

27-MAY-16

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. 773-81

Product Name: Double Barrel VP Ear Tag

• Active Ingredient(s)
  • LAMBDA-CYHALOTHRIN
    • Guarantee/concentration 6.8 %

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7. b) Type of formulation.

Other (specify)

Ear Tag

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: ear tag

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. On 31 May 2016 a veterinarian reported that on 27 may 2016 she vaccinated 27 calves and banded bulls. The calves were 1-2 months old. All calves received Vision 20/20, Vista 5, and Ivomec pour on. The bulls were banded and received tetanus toxoid. All calves received Revalor G and 1 Double Barrel Flytag. Within 30 minutes one calf had died with blood coming out of the mouth and white foam coming from both Nostrils. Had another calf show respiratory distress followed by foam coming from both nostrils and was dead by 6pm. The veterinarian necropsied the second dead calf and sent tissues samples for diagnostics. On necropsy the lungs were edematous, intra lobular edema, cranioventral lobes were purple and diffusely heavy (Coded as abnormal necropsy finding). All other tissues appeared normal. The attending veterinarian diagnosed anaphylactic reaction. No more information expected.

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

mixed breed

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.1

7. Weight (provide a range if necessary )

125

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Respiratory distress
  • Symptom - Other
  • Specify - Foam from nose

• Cardiovascular System
  • Symptom - Other
  • Specify - Blood coming out of mouth

• General
  • Symptom - Anaphylaxis
  • Symptom - Death

• Respiratory System
  • Symptom - Pulmonary edema
  • Symptom - Other
  • Specify - purple and heavy lungs

12. How long did the symptoms last?

<=30 min / <=30 min

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

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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