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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6793

2. Registrant Information.

Registrant Reference Number: 2019CA-02378

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.

06-AUG-19

5. Location of incident.

Country: CANADA

Prov / State: SASKATCHEWAN

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)

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

Product Name: Saber Pour On

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: cup approx

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 producer on 06 Aug 2019. A producer accidentally overdosed (extra label use), approximately 1 cup, her 1700 lbs bull (unknown breed) while applying Saber Pour On approximately 3.5 weeks ago. The bull has since been sold, and the new owner reported the bull has been laying around (verbatim). The onset is not known. The bull is not being treated, just observed. A follow-up is pending. Follow-up 01 Oct 2019, despite multiple attempts to contact the producer, the calls have not been returned. Nothing further is expected.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

1700

lbs

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 - Lethargy

12. How long did the symptoms last?

Unknown / Inconnu

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

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 producer on 06 Aug 2019. A producer accidentally overdosed (extra label use), approximately 1 cup, her 1700 lbs bull (unknown breed) while applying Saber Pour On approximately 3.5 weeks ago. The bull has since been sold, and the new owner reported the bull has been laying around (verbatim). The onset is not known. The bull is not being treated, just observed. A follow-up is pending. Follow-up 01 Oct 2019, despite multiple attempts to contact the producer, the calls have not been returned. Nothing further is expected.


To be determined by Registrant

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

Minor

19. Provide supplemental information here