Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3710

2. Registrant Information.

Registrant Reference Number: 2021-US-018212

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.

09-JUN-21

5. Location of incident.

Country: UNITED STATES

Prov / State: NORTH CAROLINA

6. Date incident was first observed.

31-MAY-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.       PMRA Submission No.       EPA Registration No. 2596-84

Product Name: Hartz UltraGuard Flea and Tick Collar for Dogs

• Active Ingredient(s)
  • TETRACHLORVINPHOS
    • Guarantee/concentration 14.55 %

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7. b) Type of formulation.

Other (specify)

Collar

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

Yorkshire Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

18

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Ataxia

• General
  • Symptom - Vocalizing

• Nervous and Muscular Systems
  • Symptom - Recumbent

• Eye
  • Symptom - Other
  • Specify - Eyes changed color

• Gastrointestinal System
  • Symptom - Abnormal tongue colour

• Skin
  • Symptom - Erythema

• 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?

3

Day(s) / Jour(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 23-May-2021, a 7 year old, 18 pound, neutered, male, Yorkshire Terrier dog, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Dogs (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. On 31-May-2021, the dog developed vocalization, seizures, was recumbent and unable to stand, and his eyes and tongue changed unspecified colors. The dog was evaluated by a veterinarian, the collar was removed, and application site erythema was noted. The dog was hospitalized for three days and administered unspecified medication. It was not reported if any diagnostics were performed. On 03-Jun-2021, the dog died. A necropsy was not performed and the dog was cremated. 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, that is considered to have a good margin of safety in dogs. The active ingredient is poorly absorbed across intact skin. If product residue were ingested only mild GI upset would be expected. Development of severe seizures beginning 8 days after product application and persisting until death are not anticipated. It is unknown if any diagnostics were performed and the animal owner did not have treatment details. Other causes including underlying primary CNS disease, toxin exposure, trauma. underlying metabolic disease, and severe flea bite anemia should also be considered. 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.