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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2020-0198

2. Registrant Information.

Registrant Reference Number: 2018-US-21644

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.

08-NOV-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

02-NOV-19

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.       PMRA Submission No.       EPA Registration No. 773-92

Product Name: Ultra Saber Pour On

  • Active Ingredient(s)
    • LAMBDA-CYHALOTHRIN
      • Guarantee/concentration 1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

15

Other Units: ml/600lbs

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 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up 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

Cow / Vache

3. Breed

Angus

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1.6

7. Weight (provide a range if necessary )

1100

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Death
  • Reproductive System
    • Symptom - Miscarriage
    • Specify - abortion

12. How long did the symptoms last?

Persisted until death

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

Suspected Adverse Reaction: On 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up is expected.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cow / Vache

3. Breed

Angus

4. Number of animals affected

5. Sex

Female

6. Age (provide a range if necessary )

1.6

7. Weight (provide a range if necessary )

1100

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Reproductive System
    • Symptom - Miscarriage
    • Specify - abortion

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.

Unknown

14. a) Was the animal hospitalized?

Unknown

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: On 8 Nov 2019 a veterinarian reported that one of his clients vaccinated 350 bred heifers on 01 Nov 2019 with Guardian and Preg Guard 10. The heifers were pregnancy checked, poured with Ultra Saber and Drenched with Safeguard Suspension. Within 48 hours the producer had seen 7 heifers abort and 1 heifer that died while aborting. The producer was going to try and collect any fresh abortions that may happen and send them in for testing. Further follow-up is expected.


To be determined by Registrant

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

Not Applicable

19. Provide supplemental information here