Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-4170

2. Registrant Information.

Registrant Reference Number: 2023-US-020458

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.

21-JUN-23

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

21-JUN-23

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. 2596-140

Product Name: Hartz UltraGuard Plus Flea and Tick Spray for Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .07 %
  • TETRACHLORVINPHOS
    • Guarantee/concentration 1.08 %

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7. b) Type of formulation.

Liquid

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.3

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Inappropriate defecation

• Renal System
  • Symptom - Inappropriate urination

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 20-Jun-2023, a 16 week old, approximately 12 pound, intact, female, Domestic Longhair cat, in unknown condition, with a concomitant medical condition of fleas, was administered Hartz UltraGuard Plus Flea and Tick Spray for Cats (Methoprene / Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. The owner reported they applied 4 sprays of product from the back of the cat's head to around its body. The cat appeared to be doing well throughout the night and the following morning. On 21-Jun-2023, upon returning home from work, the animal owner discovered the cat deceased and covered in urine and feces. No necropsy was performed and the cat was buried. No further information was received.

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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 wide margin of safety in cats when applied per label directions. S-methoprene is an insect growth regulator that also has a very wide safety margin in cats. The active ingredients are present in low concentration and are poorly absorbed across intact skin. If product residue was ingested only mild GI upset would be expected. Death is not consistent with the product and use described. Also, the owner approximated the cat's weight to be 12 pounds which would be very large for such a young cat. They estimated that 4 sprays of product was applied which would be an under-dose as the label states to apply 15-25 sprays to a small cat. Other causes including unknown trauma, underlying neurological disease, congenital abnormalities, severe flea-bite anemia and more should also be considered. Without diagnostics, including necropsy, the cause of death is unknown and the relationship between product use and outcome 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.