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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3708

2. Registrant Information.

Registrant Reference Number: 2021-US-016664

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.

02-JUN-21

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2596-83

Product Name: Hartz UltraGuard Flea and Tick Collar for Cats and Kittens - Purple

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

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

5

lbs

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Lethargy
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Muscle spasm
  • General
    • Symptom - Vocalizing
  • Eye
    • Symptom - Other
    • Specify - Eye disorder NOS
  • General
    • Symptom - Abnormal behaviour
  • Nervous and Muscular Systems
    • Symptom - Collapse
  • 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?

8

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 31-May-2021, a 1 year old, approximately 5 pound, neutered, female, Domestic Shorthair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens - Purple (Tetrachlorvinphos (Rabon)) via the topical route by the animal owner. This was a first time use of the product. Approximately five minutes post administration, the cat exhibited unspecified abnormal behavior and developed lethargy, adipsia and anorexia. Approximately three hours later, the cat collapsed and exhibited vocalization and muscle spasms. On 01-Jun-2021, the cat was evaluated by a veterinarian and hospitalized. The cat was administered intravenous fluids, muscle relaxants and other unknown medications. On an unknown date post clinical sign onset, euthanasia was recommended by the veterinarian. On approximately 09-Jun-2021, one eye appeared to be non-functional (eye disorder NOS) and the cat died on its own at the veterinary facility. The animal owner stated that on an unknown date prior to the Hartz collar application, the cat developed an unspecified adverse reaction to an unknown topical flea product. Two other cats in the home also had the Hartz collar applied at the same time and remained asymtomatic. No further information was received in this case.


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 is considered to have a wide margin of safety in cats. Behavioral changes are possible if a cat does not like the feeling of wearing the collar and mild GI signs (decreased appetite, drooling, vomiting) may occur if product residue is ingested via grooming. Severe neurological signs and death are not expected following dermal use or small ingestion of the product. Other causes including unknown trauma, infectious disease, underlying metabolic or cardiac disease, and toxin exposure should be considered given the young age of this cat. 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.