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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1503

2. Registrant Information.

Registrant Reference Number: 2020-US-001474

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.

30-JAN-20

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

6. Date incident was first observed.

30-JAN-20

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

  • 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

Unknown

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?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Hesitancy to move
  • Nervous and Muscular Systems
    • Symptom - Abnormal posture
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • General
    • Symptom - Weakness
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Restlessness
  • General
    • Symptom - Death

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 30-Jan-2020, a 1 year old, approximately 5 pound, female cat of unknown breed, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos) via the topical route by the animal owner. The cat was a stray that was recently found by the animal owner. Approximately 1 minute post product application, the cat became reluctant to move and she rolled on her back with her feet in the air. Approximately two hours post application, the collar was removed and the cat was rinsed with water. The prior symptoms persisted and the cat also developed fecal incontinence, weakness and anorexia. At an unspecified time post collar removal on 30-Jan-2020 the cat was bathed with degreasing dish soap by the animal owner but the symptoms persisted. Overnight, the cat developed vocalization and restlessness and fecal incontinence continued. On 31-Jan-2020, the animal owner found the cat deceased. The cat had not been evaluated by a veterinarian. It is unknown if a necropsy was performed. No further information was received.


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 cats and is not systemically absorbed following topical application. The cat's initial signs of being reluctant to move and rolling on its back were likely a behavioral response if the cat did not like the feeling of a collar in general. If ingested via grooming, only mild signs of oral irritation or gastrointestinal upset including drooling, vomiting, and decreased appetite would be expected. Weakness, fecal incontinence, anorexia, vocalization, and restlessness persisting until death are not expected following dermal use of the product. Without more information such as veterinary examination and diagnostics (including necropsy) it is difficult to assess this case further. Other causes including unknown trauma, infectious disease, severe flea bite anemia, underlying metabolic disease, and toxin exposure should be considered given the young age and unknown history 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.