Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2022-5900

2. Registrant Information.

Registrant Reference Number: 2022-US-030905

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.

12-AUG-22

5. Location of incident.

Country: UNITED STATES

Prov / State: MISSOURI

6. Date incident was first observed.

03-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 for Dogs 18oz

• 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

Crossbred

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9

7. Weight (provide a range if necessary )

8

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 - Disorientation

• General
  • Symptom - Abnormal behaviour

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Respiratory System
  • Symptom - Other
  • Specify - Bloody foam in nose
  • Symptom - Dyspnea

• Nervous and Muscular Systems
  • Symptom - Trembling

• Respiratory System
  • Symptom - Tachypnea
  • Symptom - Other
  • Specify - Fluid from nose
  • Symptom - Other
  • Specify - Agonal breathing

• General
  • Symptom - Death
  • Symptom - Other
  • Specify - Closed mouth

• Respiratory System
  • Symptom - Heavy breathing
  • Symptom - Panting
  • Symptom - Other
  • Specify - Hyperventilating

• Gastrointestinal System
  • Symptom - Foaming at mouth
  • Specify - Bloody foam

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 02-Aug-2022, a 9 year old, 8 pound, intact, male, Crossbred Canine/Dog, in unknown condition, with no known concomitant medical condition, was administered an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs 18oz (Phenothrin (Sumithrin)) via the topical route by the animal owner. This was a first time use. On 03-Aug-2022, the dog exhibited closed mouth, heavy breathing. It was described by the animal owner as the dog appeared to be panting and hyperventilating with his mouth closed. The dog was also trembling and seemed disoriented. The dog would not lay in its normal bed (abnormal behaviour) but would lay in lateral recumbency on the wood floor. On 04-Aug-2022, the dog died at home. As the dog was dying the owner described what sounded like agonal breathing and the dog had white fluid/foam coming out of his nose that contained small amounts of blood in it. The dog had not been evaluated by a veterinarian and no treatment had been performed. The dog was cremated and no necropsy was performed.

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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. The respiratory signs reported with progression to death does not fit the toxicological profile of the product. Other causes including underlying cardiac disease including heart failure, respiratory disease, and neoplasia (cancer) must also 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.