Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-3414

2. Registrant Information.

Registrant Reference Number: 2023-US-10692

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.

09-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-JUN-23

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: ULTRA Boss

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

3

Other Units: ml per 100 lbs

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 9 June 2023, a veterinarian reported that a client had 1 calf die and 3 more acting "off" or "shaky" after vaccination with Bovilis Vista Once, Bovilis Vision 7, Dectomax Injectable and poured with Ultra Boss. An unknown number of calves (estimated to be 50) were processed on 9 June 2023. Within 1 hour, 1 calf had died and 3 more reacted. Follow up pending. 23 June 2023: Evidence of severe intestinal hemorrhage. Differential diagnoses for this lesion could include jejunal hemorrhage syndrome associated with C. Perfringens. Liver copper concentration is 5.7 ppm which is very deficient. 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

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

mixed breed

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

250

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

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Other
  • Specify - Severe intestinal hemorrhage

• Liver
  • Symptom - Other
  • Specify - Copper deficient

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

---

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

Medical Professional

2. Type of animal affected

Cow / Vache

3. Breed

mixed breed

4. Number of animals affected

3

5. Sex

Unknown

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

250

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

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Abnormal behaviour
  • Specify - Acting off

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

---

To be determined by Registrant

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

Minor

19. Provide supplemental information here