Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2322

2. Registrant Information.

Registrant Reference Number: 2019-US-019782

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.

25-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

18-JUL-19

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. 2596-153

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %

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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: Personal use / Usage personnel

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: Female

Age: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Weakness

• Blood
  • Symptom - Anemia

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?

Unknown

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?

>6 mos <=1 yr / > 6 mois < = 1 an

12. Time between exposure and onset of symptoms.

>6 mos / > 6 mois

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.)

Since approximately 25-Jul-2018, a x year old, female, human, of unknown weight, in unknown condition, with no known concomitant medical conditions, was administered an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin), every other day, via the topical route (head to toe) by the patient. The woman was also using unspecified foggers in her home weekly. On approximately 18-Jul-2019, the woman exhibited weakness and was hospitalized. A complete blood count, liver panel and other unspecified blood work had been performed. All lab work values (unspecified) were low and the woman was anemic. She was administered an unknown amount of unspecified intravenous fluids, 2 Units of packed red blood cells, an unknown amount of diethylstilbestrol, folic acid, and Vitamin B12. A bone marrow biopsy had been performed and the results are unknown. The woman's doctors were unaware of product use at the time of the call. On 30-Jul-2019, the woman's daughter called to report that the woman was doing better but that she continued to be hospitalized and additional unspecified tests were still to be run. Informing the woman's doctors of her excessive product use was recommended. No further information was received in this case.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

Assessment: The active ingredient in this product is present in very low concentration and is poorly absorbed across the skin. Though the product is not intended to be used on humans, especially chronically as described in this case, it is not expected to cause generalized weakness and anemia requiring hospitalization and a transfusion. Common signs following exposure in humans can include dermal irritation, tingling sensation on the skin, eye irritation, or GI upset. Other causes should continue to be considered in this case. 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.