Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-0751

2. Registrant Information.

Registrant Reference Number: 2013-US-02934

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.

Human

4. Date registrant was first informed of the incident.

23-APR-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

20-APR-13

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. 773-95

Product Name: Activyl Tick Plus Spot-On For Dogs

• Active Ingredient(s)
  • INDOXACARB TECHNICAL
    • Guarantee/concentration 13.01 %
  • PERMETHRIN
    • Guarantee/concentration 42.5 %

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7. b) Type of formulation.

Liquid

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).

On 23 Apr 2013, a pet owner reported to the RMPDC, that a human exposure with Activyl Tick Plus Spot-On For Dogs (over 11 lb and up to 22 lb) resulted in an adverse experience. The owner applied the product on 20 Apr 2013 and while the product was still wet she touched the dog. Starting on 20 Apr 2013 and continuing into 21 Apr 2013, the pet owner felt really sick, lightheaded, sweating, got up later on in night and passed out and broke bones in face under eye and cheeks, shoulder may be dislocated. On 21 Apr 2013, owner was transported to hospital and was admitted for two days. Bleeding on brain from the fall (coded as brain damage) was determined. Has follow-up planned with primary care doctor on 29 Apr 2013. Follow-up by RMPDC, on 27 Apr 2013, the pet owner's spouse reported she has had no further return of symptoms and was still expected to follow-up with her primary care doctor on 29 Apr 2013. No further information expected.

To be determined by Registrant

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

No

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Dizziness

• Cardiovascular System
  • Symptom - Fainting

• General
  • Symptom - Sweating
  • Symptom - Other
  • Specify - fracture of facial bones after fainting

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - bleeding on the brain after fainting

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

2

Day(s) / Jour(s)

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Contact with treated area

What was the activity? Pet owner touched the application site that was still wet, same day as application.

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

On 23 Apr 2013, a pet owner reported to the RMPDC, that a human exposure with Activyl Tick Plus Spot-On For Dogs (over 11 lb and up to 22 lb) resulted in an adverse experience. The owner applied the product on 20 Apr 2013 and while the product was still wet she touched the dog. Starting on 20 Apr 2013 and continuing into 21 Apr 2013, the pet owner felt really sick, lightheaded, sweating, got up later on in night and passed out and broke bones in face under eye and cheeks, shoulder may be dislocated. On 21 Apr 2013, owner was transported to hospital and was admitted for two days. Bleeding on brain from the fall (coded as brain damage) was determined. Has follow-up planned with primary care doctor on 29 Apr 2013. Follow-up by RMPDC, on 27 Apr 2013, the pet owner's spouse reported she has had no further return of symptoms and was still expected to follow-up with her primary care doctor on 29 Apr 2013. No further information expected.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

With sincere apologies for this late submission.