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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6384

2. Registrant Information.

Registrant Reference Number: 2018-US-18570

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.

24-SEP-19

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

23-SEP-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. 773-84

Product Name: ULTRABOSS

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration 5 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

3

Other Units: ml/100lbs

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 24 September 2019 a producer reported that 2 calves died after being poured with Ultra Boss. On 23 September 2019 a group of 150 head of 525 pound calves were weighed and poured with Ultra Boss. They were then sorted into two groups and put in different pastures. One pasture had no shade and it was a very hot an humid day. In the pasture with no shade ~10 calves were panting and breathing heavy. He opened a gate so they could get shade however 2 calves never found the shade and died. The other 8 calves recovered. The producer was concerned the Ultra Boss caused this issue. The calves were not necropsied and no diagnostic work was done. No more information expected.

To be determined by Registrant

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

Unknown

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

2

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

525

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

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Respiratory System
    • Symptom - Laboured breathing
    • Symptom - Panting
  • General
    • Symptom - Death

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 24 September 2019 a producer reported that 2 calves died after being poured with Ultra Boss. On 23 September 2019 a group of 150 head of 525 pound calves were weighed and poured with Ultra Boss. They were then sorted into two groups and put in different pastures. One pasture had no shade and it was a very hot an humid day. In the pasture with no shade ~10 calves were panting and breathing heavy. He opened a gate so they could get shade however 2 calves never found the shade and died. The other 8 calves recovered. The producer was concerned the Ultra Boss caused this issue. The calves were not necropsied and no diagnostic work was done. No more information 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 catte

4. Number of animals affected

8

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

525

lbs

8. Route(s) of exposure

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

  • Respiratory System
    • Symptom - Panting
    • Symptom - Laboured breathing

12. How long did the symptoms last?

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

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

Fully Recovered / Complètement rétabli

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 24 September 2019 a producer reported that 2 calves died after being poured with Ultra Boss. On 23 September 2019 a group of 150 head of 525 pound calves were weighed and poured with Ultra Boss. They were then sorted into two groups and put in different pastures. One pasture had no shade and it was a very hot an humid day. In the pasture with no shade ~10 calves were panting and breathing heavy. He opened a gate so they could get shade however 2 calves never found the shade and died. The other 8 calves recovered. The producer was concerned the Ultra Boss caused this issue. The calves were not necropsied and no diagnostic work was done. No more information expected.


To be determined by Registrant

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

Not Applicable

19. Provide supplemental information here