Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2024-2054

2. Registrant Information.

Registrant Reference Number: 2024-CA-000162

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.

19-APR-24

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-MAR-19

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. 30732      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Flea and Tick Drops for Dogs 2.5 - 6 kg

• Active Ingredient(s)
  • D-PHENOTHRIN

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7. b) Type of formulation.

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

Terrier - West Highland White/Shih Tzu crossbred

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

14

7. Weight (provide a range if necessary )

2.6

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Anorexia

• Respiratory System
  • Symptom - Rapid breathing

• Gastrointestinal System
  • Symptom - Vomiting

• Respiratory System
  • Symptom - Pulmonary edema

• Cardiovascular System
  • Symptom - Other
  • Specify - Congestive heart failure

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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 07-Apr-2024, a 14 year old, approximately 2.6 kilogram, neutered, female, Terrier - West Highland White/Shih Tzu crossbred dog, in unknown condition, with concomitant medical conditions of arthritis and anxiety, was administered1 tube of Hartz UltraGuard Flea and Tick Drops for Dogs 2.5 - 6 kg (Phenothrin (Sumithrin)) via the topical route by the animal owner. The dog was concurrently administered gabapentin at an unspecified dose and frequency, via an unknown route by the animal owner. Approximately 4 hours post application, the dog developed lethargy. On 08-Apr-2024, the dog developed anorexia, rapid breathing, and several episodes of vomiting. On 10-Apr-2024, the dog was evaluated by a veterinarian. Multiple diagnostics were performed including chest radiographs, a complete blood count, and an unspecified chemistry panel. Fluid in the lungs (pumonary edema) was detected and the dog was diagnosed with congestive heart failure. The dog was sent home and administered pimobendan and furosemide (unspecified doses and routes) by the animal owner, as directed by the veterinarian. The clinical signs were significantly improved by 13-Apr-2024. On 16-Apr-2024, the rapid breathing worsened. The animal owner consulted with the veterinarian over the phone and was instructed to administer another dose of furosemide. The dog died later that evening. The veterinarian reported to the animal owner that the dog's clinical signs, diagnoses and death were unrelated to the product but were due to diagnosed congestive heart failure. The dog had also been administered the product monthly, March - November, since approximately 01-Mar-2019. Approximately 4 hours after each monthly application the dog developed mild lethargy that lasted approximately 24 hours, then resolved without treatment. No further information is expected.

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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 has a wide margin of safety in dogs and was used numerous times on this dog without incident. Development of congestive heart failure does not fit the toxicological profile of the product. The treating veterinarian also informed the owner that development of heart failure and subsequently death was not related to product use. Congestive heart failure is a relatively common condition in older dogs and often related to degenerative mitral valve disease, especially in smaller breeds. 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.