Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5894

2. Registrant Information.

Registrant Reference Number: 2022-CA-000417

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.

29-SEP-22

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

26-SEP-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. 30730      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg Spot-on

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

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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.

Other

2. Demographic information of data subject

Sex: Male

Age: >1 <=6 yrs / > 1 < = 6 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Diarrhea
  • Symptom - Vomiting
  • Symptom - Anorexia
  • Symptom - Abnormal tongue colour

• General
  • Symptom - Fever

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

Day(s) / Jour(s)

What was the activity? slept in dog bed with treated dog

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

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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 26-Sep-2022, an 18 month old, 13.6 kilogram, male human, with concomitant medical condition of chronic ear infections, was potentially exposed to an unknown amount of Hartz UltraGuard Pro Drops for Dogs 14 - 28 kg (Phenothrin (Sumithrin) / S Methoprene) via the topical route. This was an extra label use due to accidental secondary exposure. The product was applied to the dog in the home on 25-Sep2022. On 26-Sep-2022, the child slept with the dog in the dog bed and may have gotten some of the product on his skin. Approximately 8 hours later the child developed diarrhea. On approximately 27-Sep-2022 the child developed anorexia and a fever. The child was given acetaminophen at home for the fever which then resolved an unspecified amount of time later. On 28-Sep-2022 the child developed vomiting (two episodes). On 29-Sep-2022, the child developed red blotches on his tongue. The child had not been evaluated by a physician. Given the persistent signs, evaluation by a pediatrician was recommended. Two attempts at follow-up were made but messages were not returned. 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.