Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-2660

2. Registrant Information.

Registrant Reference Number: 2020-CA-000202

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.

Domestic Animal

4. Date registrant was first informed of the incident.

22-JUN-20

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

06-JUN-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. 28356      PMRA Submission No.       EPA Registration No.

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

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 14.55 %

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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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

12

7. Weight (provide a range if necessary )

4.08

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Abnormal behaviour

• Skin
  • Symptom - Pruritus
  • Symptom - Erythema
  • Symptom - Blister
  • Symptom - Lesion
  • Symptom - Red skin

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement rétabli

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On 30-May-2020, a 12 year old, 4.08 kilogram, neutered, male, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of UltraGuard Reflective Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. On approximately 06-Jun-2020, the cat exhibited scared behavior and was hiding. On approximately 12-Jun-2020, the cat developed application site pruritus. On approximately 13-Jun-2020, the skin underneath the collar was red, scabbed, and blistering; similar to that of a rope burn and the collar was removed. Later that same day, at an unspecified time post product removal, the clinical signs improved. On approximately 15-Jun-2020, the clinical signs resolved and the cat recovered without medical intervention. The animal owner used other unspecified flea collars previously on unspecified dates, but this was their first time using a collar that offered both flea and tick protection.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Assessment: Blisters are not anticipated after application of product. If the pet does not like the sensation of product on the skin, pruritus may occur. If scratching is persistent, the skin may become damaged and a sore could develop. Hypersensitivity may occur with any topical product and may be related to either the product's active or inactive ingredients. 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.