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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5340

2. Registrant Information.

Registrant Reference Number: 2495589

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

Address: 400 Plaza Drive

City: Seacaucus

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.

06-AUG-19

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

03-AUG-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. 25621      PMRA Submission No.       EPA Registration No.

Product Name: UltraGuard Flea and Tick Collar for Cats and Kittens

  • Active Ingredient(s)
    • TETRACHLORVINPHOS

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?

Yes

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

  • Cardiovascular System
    • Symptom - Arrhythmia
  • General
    • Symptom - Taste altered
    • Specify - Funny taste in mouth

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?

No

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

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

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

12. Time between exposure and onset of symptoms.

>8 hrs <=24 hrs / > 8 h < = 24 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.)

8/6/2019 Caller put the collar on his cat on 8/2/2019. He removed the collar the next morning 8/3/2019, and caller developed a funny taste in his mouth that evening. He went to the emergency department the evening of 8/3/2019. Blood tests were not remarked on, but an electrocardiogram showed an irregular heart beat. He was referred to his regular doctor who he has not seen yet. The doctor told him he must have had a mild case of poisoning from the product. He did not answer when asked if he was given a diagnosis. The bad taste resolved by the time he left the emergency department. He declined to provide past medical history or further information.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

Assessment: Exposure to this product in the manner described is not expected to result in systemic symptoms. Animal models have shown no acetylecholinesterase (AChE) inhibition from dermal exposure to the active ingredient in this product. Furthermore, AChE inhibition, if it were to occur, would be expected to result in a decrease in heart rate, rather than a heart rhythm irregularity. While it is conceivable that hand to mouth transfer of product residue could result in a taste alteration, that is expected to occur immediately upon exposure, rather than several hours later. Alternative etiologies for the consumer's symptoms should be explored. 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.