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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-1504

2. Registrant Information.

Registrant Reference Number: 2020-US-003034 and 2020-US-003036 (linked cases)

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.

26-FEB-20

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

Unknown

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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Blister
  • Gastrointestinal System
    • Symptom - Anorexia
  • 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 an unspecified date in Nov-2019, a 5 year old, approximately 7 pound, neutered, female, Maine Coon cat, in unknown condition, with concomitant medical condition of fleas was administered an unknown amount of an unspecified flea and tick shampoo via the topical route by the animal owner and the cat was also administered an unknown amount of nitenpyram via the oral route by the animal owner. On 02-Nov-2019, the cat was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos) via the topical route by the animal owner. On an unspecified date in Nov-2019 post product application, the cat developed application site hair loss, application site blisters, and anorexia. On approximately 28-Nov-2019, the cat died. The cat was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. The animal owner also reported applying the product to a male cat of unknown age, weight, breed, with concomitant fleas on an unspecified date. This cat died an unspecified amount of time later. No other information about this cat was provided and no other symptoms were reported. 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 is considered to have a wide margin of safety in cats. Occasionally individual sensitivities may occur. Application site reactions and hair loss are possible following use of any topical product. However, severe symptoms and death are not expected. Without more information including veterinary examination findings and diagnostics (including necropsy) it is difficult to assess this case further. Other causes including severe flea bite anemia, underlying metabolic disease, infectious disease, and cancer should be considered in the deaths of both cats. 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.

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

Male

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • 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 an unspecified date in Nov-2019, a 5 year old, approximately 7 pound, neutered, female, Maine Coon cat, in unknown condition, with concomitant medical condition of fleas was administered an unknown amount of an unspecified flea and tick shampoo via the topical route by the animal owner and the cat was also administered an unknown amount of nitenpyram via the oral route by the animal owner. On 02-Nov-2019, the cat was administered 1 collar of Hartz UltraGuard Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos) via the topical route by the animal owner. On an unspecified date in Nov-2019 post product application, the cat developed application site hair loss, application site blisters, and anorexia. On approximately 28-Nov-2019, the cat died. The cat was not evaluated by a veterinarian and no treatments were performed. It is unknown if a necropsy was performed. The animal owner also reported applying the product to a male cat of unknown age, weight, breed, with concomitant fleas on an unspecified date. This cat died an unspecified amount of time later. No other information about this cat was provided and no other symptoms were reported. 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 is considered to have a wide margin of safety in cats. Occasionally individual sensitivities may occur. Application site reactions and hair loss are possible following use of any topical product. However, severe symptoms and death are not expected. Without more information including veterinary examination findings and diagnostics (including necropsy) it is difficult to assess this case further. Other causes including severe flea bite anemia, underlying metabolic disease, infectious disease, and cancer should be considered in the deaths of both cats. 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.