Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2315

2. Registrant Information.

Registrant Reference Number: 2020-CA-000076

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.

17-APR-20

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-APR-20

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. 29930      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard OneSpot Flea and Tick Cat Drops

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

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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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Eye
  • Symptom - Burning eye

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)

Contact with treated area

Amount of time between application and contact 1

Hour(s) / Heure(s)

What was the activity? Please refer to field 13 on Subform II or field 17 of subform III for a detailed description regarding the activity

Other

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

Unknown

10. Route(s) of exposure.

Skin

Eye

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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 17-Apr-2020, a male, human, of unknown age and weight, in unknown condition, with no known concomitant medical condition, applied the product to his cat without washing his hands afterwards. Approximately one hour later, he pet his cat at the application site and touched the corner of his eye with the same hand. Immediately after, the man developed a burning sensation in his eye and rinsed his eyes out with water. Continuing to rinse the eyes with lukewarm, running water for another 15-20 minutes, discarding any contact lenses worn at the time of exposure, avoiding bright lights for the next 2 hours and seeking medical attention if the clinical sign persisted or worsened, were discussed. No further information was received in this case.

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 can not 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.