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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6276

2. Registrant Information.

Registrant Reference Number: 2019-CA-000155

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.

26-OCT-19

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

16-OCT-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)

PMRA Registration No. 31724      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Rid Flea Dog Shampoo - Fresh Scent

  • Active Ingredient(s)
    • D-PHENOTHRIN

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?

Unknown

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

3. List all symptoms, using the selections below.

System

  • Gastrointestinal System
    • Symptom - Gagging
  • Nervous and Muscular Systems
    • Symptom - Muscle pain
  • Respiratory System
    • Symptom - Dyspnea
  • Gastrointestinal System
    • Symptom - Retching

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)

Chemical resistant gloves

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.

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 approximately 16-Oct-2019, a x year old, 100 pound, female, human, in unknown condition, with concomitant medical conditions COPD, peptic ulcers, acid reflux, who smokes, has allergies to grass, trees, and dust, and who takes Spiriva (tiotropium), Alvesco (ciclesonide), an albuterol inhaler, and an unknown medication for acid reflux, was exposed to an unknown amount of Hartz UltraGuard Rid Flea Dog Shampoo Fresh Scent (Phenothrin) while bathing her dog with the product. The woman wore gloves while bathing the dog, then removed them while blow drying the dog. An unspecified amount of time later, she began to experience gagging, dry heaves (retching), pain in her abdominal muscles, and dyspnea. She treated her symptoms herself by taking unspecified amounts of her normal medications, and continued to be symptomatic at the time of the call (26-Oct-2019). Follow-up was attempted but no further information was received in this case.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Assessment: This product is considered to have a wide margin of safety due to the low concentration of pyrethroid present. If dermal exposure occurs, skin irritation and a temporary tingling sensation may occur. The signs described in this case and their prolonged duration are not expected and are more likely related to underlying medical conditions, though individual sensitivities may exist. 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.