Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-3666

2. Registrant Information.

Registrant Reference Number: 2022-US-021839

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.

20-JUN-22

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

19-JUN-22

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 - Purple

• 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Ragdoll

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Respiratory System
  • Symptom - Epistaxis
  • Symptom - Dyspnea

• Nervous and Muscular Systems
  • Symptom - Muscle twitching

• General
  • Symptom - Death

• Eye
  • Symptom - Discharge eye

12. How long did the symptoms last?

Unknown / Inconnu

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

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 19-Jun-2022, a 10 year old, 10 pound, neutered, female, Ragdoll cat, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens - Purple (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. Two hours after application, the cat developed abnormal breathing (dyspnea), epistaxis, and eye discharge (crusty eyes). The collar was removed and the animal owner wiped the application site. It is unknown what was used to wipe the application site. The epistaxis resolved a few hours after onset and the cat seemed to calm down. On 20-Jun-2022, the cat made a twitching motion and the owner drove her to the vet. The cat died en route to the veterinary facility. The animal owner elected to have a necropsy performed but no results have been received. No further information was received in this case.

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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. Severe signs progressing to death are not expected and other causes including underlying cardiac disease, unknown trauma, and infectious disease should also be considered in this case. Without necropsy results, 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.