Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3704

2. Registrant Information.

Registrant Reference Number: 2021-CA-000177

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.

13-JUL-21

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

13-JUL-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)

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PMRA Registration No. 25654      PMRA Submission No.       EPA Registration No.

Product Name: Hartz UltraGuard Flea and Tick Dog Spray

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 1.08 %

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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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Rough Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

36

kg

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

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

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure

• Respiratory System
  • Symptom - Pulmonary edema

• Cardiovascular System
  • Symptom - Cardiac arrest

• General
  • Symptom - Death

12. How long did the symptoms last?

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

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?

8

Hour(s) / Heure(s)

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 12-Jul-2021, an 11 year old, 36 kg, neutered, male, Collie - Rough-Haired dog, in unknown condition, with concomitant medical conditions of fleas, was administered 1-2 sprays of Hartz UltraGuard Flea and Tick Dog Spray (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. This was an extra label use due to the low dose applied to the dog. Approximately 11 hours post-application, on 13-Jul-2021, the dog developed seizures. The dog was taken to a veterinarian where seizures persisted and the dog was noted to have pulmonary edema. Unknown treatments were performed by the veterinarian but the seizures persisted. The dog went into cardiac arrest and died later that same day. It was not reported if any diagnostics, including necropsy, were performed. The product had been used on the dog previously during the summer of 2020 without incident. No further information was received in this case.

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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 tetrachlorvinphos, an organophosphate insecticide, in low concentration and has a wide margin of safety in dogs. Only 1-2 sprays were applied to this large dog which is a very low dose compared to the label directions to apply the product to the entire coat of the dog. Even if the product was ingested while still wet on the fur, only mild GI upset would be expected. Other causes for the severe and persistent signs in this case, including a brain tumor, infectious disease, severe flea anemia, toxin exposure, and underlying metabolic disease. 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.