Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-5907

2. Registrant Information.

Registrant Reference Number: 2021-US-040375

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-SEP-21

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

18-SEP-21

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)

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-153

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %

---

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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Shih Tzu

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

8

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

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Went limp

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Unresponsive

• Eye
  • Symptom - Other
  • Specify - Eyes looked grey

• General
  • Symptom - Other
  • Specify - Tongue hanging out

• Nervous and Muscular Systems
  • Symptom - Seizure

• Cardiovascular System
  • Symptom - Tachycardia
  • Symptom - Cardiac arrest

• 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 18-Sep-2021, a 1 year old, 8 pound, female, Shih Tzu dog, in unknown condition, with a concomitant medical condition of fleas, was administered a small, unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner's girlfriend. This was a first time use of the product. Approximately 20 minutes later, the dog's body went limp. The dog vomited white foam, was vocalizing, eyes appeared to be gray, and her tongue was hanging out. The dog was evaluated at an emergency veterinary facility and was administered charcoal and unspecified intravenous fluids. The dog was then discharged and brought home that evening. The dog's body continued to be limp and she was unresponsive. Throughout the night she laid quietly in her bed. The morning of 19-Sep-2021, the dog started vocalizing again and developed an increased heart rate. The dog was evaluated by a different veterinarian. There, the dog was bathed with an unspecified shampoo and administered unspecified intravenous fluids. While at the veterinary facility the dog went into cardiac arrest. Cardiopulmonary resuscitation was performed but the dog arrested again and died. The animal owner believes the dog also developed a seizure at an unspecified time after product administration. No additional flea product had been administered to the dog and the animal owner believes the dog did not drink any bath water. No necropsy was performed. The dog was cremated.

---

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. Severe signs persisting until death are certainly not anticipated and other causes should be considered including aspiration during bathing, vaso-vagal response after vomiting, underlying cardiac disease, severe flea-bite anemia, and unknown trauma. Without a 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.