Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1484

2. Registrant Information.

Registrant Reference Number: 2024-US-000751

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

Address: 200 Plaza Drive, Suite 402

City: Secaucus

Prov / State: New Jersey

Country: USA

Postal Code: 07094

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

10-JAN-24

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

06-JAN-24

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. 2596-83

Product Name: Hartz UltraGuard 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.

Other (specify)

Collar

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 )

0.25

7. Weight (provide a range if necessary )

1.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Hiding
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Seizure

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2

Day(s) / Jour(s)

15. Outcome of the incident

Died

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 05-Jan-2024, a 0.25 year old, approximately 1 pound, intact, male, Domestic Shorthair cat, in unknown condition, with a concomitant medical condition of fleas, had 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens - Purple (Tetrachlorvinphos (Rabon)) placed around the neck by the animal owner. On 06-Jan-2024, the cat appeared frightened (abnormal behaviour), and was hiding in the closet. After removing him from the closet, the cat developed a seizure and the animal owner consulted with a veterinarian over the phone. The collar was removed and the cat was bathed multiple times with dish soap via the topical route, as directed by the veterinarian. At an unknown amount of time post bathing, the seizure resolved and the cat rested comfortably. On approximately 08-Jan-2024, the cat developed multiple seizures and was brought to a veterinary facility for evaluation. The cat was hospitalized and administered an unspecified sedative via an unknown route and unspecified intravenous fluids by the veterinarian. After the treatments were administered, the cat appeared stable. On 10-Jan-2024, the cat died at the hospital. No further information regarding any new clinical signs prior to death was provided. A diagnosis was not provided and a necropsy was not performed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: This product contains tetrachlorvinphos, an organophosphate insecticide, that is considered to have a good margin of safety in cats. The active ingredient is poorly absorbed across intact skin. If product residue were ingested only mild GI upset would be expected. The initial behavioral change exhibited by the cat may have been related to the cat simply not liking the feeling of having the collar on. Seizures and death are not expected and other causes including underlying severe flea bite anemia, infectious disease, neurological conditions, congenital defects, unknown trauma or toxin exposure should also be considered in this case. Without diagnostics, including necropsy, the cause of death remains unknown and the relationship to product use is inconclusive. 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.