Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1704

2. Registrant Information.

Registrant Reference Number: 2017-CA-00205

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.

14-FEB-17

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

14-FEB-17

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. 25488      PMRA Submission No.       EPA Registration No. 773-82

Product Name: Boss Pour-On

• Active Ingredient(s)
  • PERMETHRIN

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

30

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).

Suspected adverse reaction reported on 14 Feb 2017. A beef manager reported that on 13 Feb 2017 they gave 30 ml of Boss Pour On to 500 head of cattle weighing from 1000 pounds to 1200 pounds. They also received a non-company hormonal implant at the same time. On 14 Feb 2017, they reported that 1 steer and 2 heifers seem to have nervous like symptoms, they are down in their home pen. All 3 were treated with dexamethasone and thiamine but so far there is no response to treatment. The steer was paddling and will be euthanized. They highly suspect a Histophilus infection in this steer, they will perform a gross post-mortem but it is unlikely further testing will be performed. The 2 heifers are down but bright and alert, and one has a long term treatment history long before processing with Boss Pour On. The vet feels that the 3 cases are unrelated. Follow-up expected.Follow-up 03 Mar 2017: All 3 affected beef were euthanized between 14 and 18 Feb 2017 and no other beefs were down after that episode, the vet feels it was incidental issues. The heifer had a chronic pneumonia, the vet still suspect Histophilus in the steer and nothing was found on the third one but they suspect neck injury. 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

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Beef cattle

4. Number of animals affected

3

5. Sex

Male

Female

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?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - neurological signs, not described
  • Symptom - Recumbent

• General
  • Symptom - Other
  • Specify - abnormal necropsy findings; signs of Histophilus

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - paddling

• Respiratory System
  • Symptom - Pneumonia

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.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Euthanised / Euthanasie

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