Health Canada
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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

Update the report

Incident Report Number: 2018-6058

2. Registrant Information.

Registrant Reference Number: 2018-US-17695

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.

04-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

03-SEP-18

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 04 Sept 2018 a producer reported that he worked approximately 110 head of calves on 03 Sept 2018 with Vista Once, Ultrabac 7 and poured with Ultra Saber. The producer stated that another group of 110 was brought in later that evening and worked with Vista Once, Ultrabac 7 and poured with Ultra Saber and one of the last calves worked went down out of the chute and died. The producer stated that they then went down and looked through the other group of calves and found 2 others that were dead. All the vaccines were given on the left side of the neck and approximately 20 calves showed soreness in the left front leg. The calves are being taken in for necropsies work and diagnostics. The producer didn't report his expected morbidity and mortality rates of the farm, but the standard rates are 1.5% morbidity and 8.5% mortality. 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

beef cattle

4. Number of animals affected

3

5. Sex

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Anaphylaxis

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 04 Sept 2018 a producer reported that he worked approximately 110 head of calves on 03 Sept 2018 with Vista Once, Ultrabac 7 and poured with Ultra Saber. The producer stated that another group of 110 was brought in later that evening and worked with Vista Once, Ultrabac 7 and poured with Ultra Saber and one of the last calves worked went down out of the chute and died. The producer stated that they then went down and looked through the other group of calves and found 2 others that were dead. All the vaccines were given on the left side of the neck and approximately 20 calves showed soreness in the left front leg. The calves are being taken in for necropsies work and diagnostics. The producer didn't report his expected morbidity and mortality rates of the farm, but the standard rates are 1.5% morbidity and 8.5% mortality. 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

beef cattle

4. Number of animals affected

20

5. Sex

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Pain
    • Specify - leg pain

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

uspected Adverse Reaction: On 04 Sept 2018 a producer reported that he worked approximately 110 head of calves on 03 Sept 2018 with Vista Once, Ultrabac 7 and poured with Ultra Saber. The producer stated that another group of 110 was brought in later that evening and worked with Vista Once, Ultrabac 7 and poured with Ultra Saber and one of the last calves worked went down out of the chute and died. The producer stated that they then went down and looked through the other group of calves and found 2 others that were dead. All the vaccines were given on the left side of the neck and approximately 20 calves showed soreness in the left front leg. The calves are being taken in for necropsies work and diagnostics. The producer didn't report his expected morbidity and mortality rates of the farm, but the standard rates are 1.5% morbidity and 8.5% mortality. Further follow-up is expected.


To be determined by Registrant

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

Minor

19. Provide supplemental information here