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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1259

2. Registrant Information.

Registrant Reference Number: 2020-CA-00540

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.

18-MAR-20

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

17-MAR-20

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)

PMRA Registration No. 25488      PMRA Submission No.       EPA Registration No.

Product Name: Boss Pour On

  • Active Ingredient(s)
    • PERMETHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.5

Other Units: 1.5 mL per 23 kg/animal

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 flock vet on 18 March 2020. A producer sheared a flock of pregnant ewes on 14 Mar 2020. The ewes are due to lamb approximately 21 Mar 2020. The producer treated 15 pregnant ewes, infested with lice, with Boss Pour-On on 16 Mar 2020, following label dose and route of administration. On the morning of 17 Mar 2020, the producer found one ewe was down and called her veterinary clinic. The veterinarian was not asked to go to the farm to examine the ewe. Based on the clinical history and clinical signs, the veterinarian prescribed and dispensed medication to treat the ewe for pneumonia and pregnancy toxemia. The veterinarian does not believe there is a correlation with the reaction and the product. A follow-up is pending.Follow-up 20 April 2020, after multiple requests for follow-up information, none has been forth coming. Nothing further is 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

Sheep / Mouton

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

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

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - down
  • Respiratory System
    • Symptom - Pneumonia
  • General
    • Symptom - Other
    • Specify - pregnancy toxemia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 flock vet on 18 March 2020. A producer sheared a flock of pregnant ewes on 14 Mar 2020. The ewes are due to lamb approximately 21 Mar 2020. The producer treated 15 pregnant ewes, infested with lice, with Boss Pour-On on 16 Mar 2020, following label dose and route of administration. On the morning of 17 Mar 2020, the producer found one ewe was down and called her veterinary clinic. The veterinarian was not asked to go to the farm to examine the ewe. Based on the clinical history and clinical signs, the veterinarian prescribed and dispensed medication to treat the ewe for pneumonia and pregnancy toxemia. The veterinarian does not believe there is a correlation with the reaction and the product. A follow-up is pending. Follow-up 20 April 2020, after multiple requests for follow-up information, none has been forth coming. Nothing further is expected.


To be determined by Registrant

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

Major

19. Provide supplemental information here