Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5901

2. Registrant Information.

Registrant Reference Number: 2022-US-031240

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.

15-AUG-22

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

09-AUG-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. 2596-153

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

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

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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?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever/German Shepherd crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

20

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Hair loss

• Gastrointestinal System
  • Symptom - Anorexia

• General
  • Symptom - Adipsia

• Renal System
  • Symptom - Urinary incontinence

• Gastrointestinal System
  • Symptom - Diarrhea

• Renal System
  • Symptom - Renal failure

• 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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 08-Aug-2022, a 0.5 year old, approximately 20 pound, non-pregnant non-lactating, female, Labrador Retriever /German Shepherd dog, in unknown condition, with concomitant medical condition of fleas, was administered 1 dose of Hartz UltraGuard Rid Flea and Tick Shampoo with Oatmeal for Dogs (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was a first time use. On 09-Aug-2022, the dog developed hair loss at the tail base. On 11-Aug-2022, the dog developed anorexia. On 12-Aug-2022, the dog developed diarrhea, adipsia and urinary incontinence. The dog was evaluated by a veterinarian and hospitalized. Blood work was performed which indicated renal failure. A fecal exam was performed and no abnormalities were detected. A urinalysis may also have been run but the owner was unsure. The dog was administered unspecified intravenous fluids, unspecified kidney failure medication and unspecified stomach medication. The dog passed away on 15-Aug-2022. No necropsy was performed. Another dog in the household was also bathed using the product on 08-Aug-2022, and it also experienced an adverse reaction. On 10-Aug-2022, that dog developed a seizure and was hospitalized for observation. No additional symptoms developed. The dog was administered oral antibiotics. Blood work and a urinalysis were performed with no abnormalities detected. On 13-Aug-2022, the dog recovered.

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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 and transient signs of GI upset would be expected. Development of anorexia, diarrhea, urinary incontinence, and renal failure progressing to death does not fit the toxicological profile of the product. Other causes including infectious disease, dietary indiscretion, and toxin exposure (grapes/raisins, antifreeze, NSAIDs like ibuprofen, etc.) should all be considered. 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.