Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2023-1702

2. Registrant Information.

Registrant Reference Number: 2023-US-002927

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.

09-FEB-23

5. Location of incident.

Country: UNITED STATES

Prov / State: ARIZONA

6. Date incident was first observed.

08-FEB-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. 2596-177

Product Name: Hartz Ultraguard Pro Triple Active Flea and Tick Shampoo for Dogs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .04 %
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %
  • PYRIPROXYFEN
    • Guarantee/concentration .075 %

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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?

No

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

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Shaking

• General
  • Symptom - Vocalizing
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Dyspnea

• Renal System
  • Symptom - Other
  • Specify - Urinary tract obstruction

• General
  • Symptom - Death

• Respiratory System
  • Symptom - Mouth breathing

12. How long did the symptoms last?

Persisted until death

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

Unknown

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 07-Feb-2023, a 3 year old, 6 pound, intact, male, Domestic Longhair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 application of Hartz Ultraguard Pro Triple Active Flea and Tick Shampoo for Dogs (Methoprene / Phenothrin (Sumithrin) / Pyriproxifen (Nylar)) via the topical route by the animal owner. This was an extra label use due to species. On 08-Feb-2023, the cat developed shaking, open mouth breathing (dyspnea), and vocalization. The clinical signs occurred approximately every 30 minutes. The cat also developed lethargy, vomiting and anorexia. The animal owner used a dropper to administer water to the cat but no additional at home treatment was performed. In the evening of 09-Feb-2023, the cat was evaluated by a veterinarian at an emergency veterinary facility. The cat was diagnosed with a urinary tract obstruction and died. It was not specified if any treatment was performed prior to the cat's death. The owner stated the cat's signs were not related to product use. 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 active ingredients all in low concentration. Even with misuse on cat, severe effects are not expected. The cat was diagnosed by a veterinarian as having a urinary obstruction and subsequently died. Urinary obstructions are an emergency and may lead to death if not treated promptly. 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.