Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-4376

2. Registrant Information.

Registrant Reference Number: 2022-US-15372

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.

17-AUG-22

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-AUG-22

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)

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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 %

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7. b) Type of formulation.

Liquid

Other (specify)

pour on

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 17 Aug 2022, a veterinarian reported that a client reported that his hired help sprayed an entire gallon of Ultra Boss on 12 head of 1500-1800 pound 18 month old Brangus bulls off label. The veterinarian reported that it was a very hot humid day and they were getting the bulls ready for sale pictures. A few hours later, they found 2 of the bulls dead. The veterinarian felt that the bulls got overheated and died of heat exhaustion. The veterinarian was going to talk to the owner about necropsying the bulls and reported that the other 10 bulls were doing fine. No further follow up 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

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

Brangus

4. Number of animals affected

2

5. Sex

Male

6. Age (provide a range if necessary )

1.5

7. Weight (provide a range if necessary )

1500

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

<=30 min / <=30 min

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

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To be determined by Registrant

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

Death

19. Provide supplemental information here