Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-1477

2. Registrant Information.

Registrant Reference Number: 2024-US-007369

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.

26-MAR-24

5. Location of incident.

Country: UNITED STATES

Prov / State: MARYLAND

6. Date incident was first observed.

23-MAR-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. 2596-177

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

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

6

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Disorientation

• 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?

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 23-Mar-2024, a 6 year old, 5 pound, female, Chihuahua dog, in unknown condition, with no known concomitant medical conditions, was bathed twice using Hartz Ultraguard Pro Triple Active Flea and Tick Shampoo for Dogs (Methoprene / Phenothrin (Sumithrin) / Pyriproxifen (Nylar)) by the animal owner. The dog was bathed using a quarter-sized dollop of shampoo, rinsed, then bathed and rinsed again. This was extra label use due to overdose and bathing twice in row. Approximately 2-3 hours post application, the dog developed two seizures. The longest seizure lasted two minutes and afterwards the dog was disoriented for an unspecified amount of time. On 24-March-2024, the dog had three more seizures and the owner attempted to bathe the product off using water only. On 25-March-2024, the dog had four seizures. On 26-Mar-2024, the dog had three seizures. The animal owner contacted a veterinarian but no appointments were available. The closest emergency veterinary facility was three hours away and the animal owner was unable to bring the dog. Since veterinary care was unable to be sought that day, the animal owner was advised to bathe the dog 2-3 times using liquid dish soap for product removal. It is unknown if this was performed. On 27-Mar-2024, the dog was evaluated at the emergency veterinary facility. Unspecified diagnostics and treatments were performed. The dog died at the veterinary facility an unspecified amount of time later on 27-Mar-2024. A necropsy was not performed. 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 a pyrethroid insecticide in low concentration giving it a very wide margin of safety in dogs. Even if the product was ingested directly during bathing only minor signs of GI upset would be expected. Persistent seizures progressing to death are certainly not anticipated even in the event of an overdose. Other causes should be considered including underlying neurological conditions, metabolic diseases, unknown trauma, toxin exposure, and severe flea-bite anemia. Without results of veterinary evaluation and 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.