Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-3656

2. Registrant Information.

Registrant Reference Number: 2022-CA-000164

Registrant Name (Full Legal Name no abbreviations): The Hartz Mountain Corporation

Address: 400 Plaza Drive

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094-3688

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

20-MAY-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

20-MAY-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. 29720      PMRA Submission No.       EPA Registration No.

Product Name: UltraGuard Plus Reflective Flea and Tick Collar for Dogs and Puppies

• Active Ingredient(s)
  • (S)-METHOPRENE
  • TETRACHLORVINPHOS

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7. b) Type of formulation.

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).

Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding application.

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: Male

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Dizziness

4. How long did the symptoms last?

Unknown / Inconnu

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

No

6. a) Was the person hospitalized?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

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?

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

12. Time between exposure and onset of symptoms.

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

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 20-May-2022, a [age] year old, [weight] pound, male, human, with a concomitant medical thyroid condition, and takes an unknown amount of Synthroid (levothyroxine sodium) medication daily, was exposed to an unknown amount of UltraGuard Plus Reflective Flea and Tick Collar for Dogs and Puppies (Tetrachlorvinphos (Rabon) / S Methoprene) via the topical route. This was an extra label use due to secondary exposure. While applying the collar to their dog the man adjusted the fit several times and noted a lot of powder on the collar. After handling, he washed his hands several times with soap and water. The dog stayed in close contact with the human after product application. Approximately 90 minutes after handling the collar, the human developed intermittent dizziness, described as feeling similar to motion sickness. He removed the collar from the dog and placed it in a plastic bag. He then sat down and drank water to alleviate the symptoms. He was advised to wash his hands for 15-20 minutes, get 30 minutes of fresh air, and drink plenty of water. If symptoms persisted or worsened, immediate medical evaluation in the ER was recommended. No further information was received.

To be determined by Registrant

14. Severity classification.

Minor

15. Provide supplemental information here.

The information contained in this report is based on self-reported statements provided to the registrant during telephone interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.