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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2021-3707

2. Registrant Information.

Registrant Reference Number: 2021-US-014996

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.

24-MAY-21

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

05-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. 2596-139

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

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 1.02 %
    • 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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11

7. Weight (provide a range if necessary )

5

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

>3 days <=1 wk / >3 jours <=1 sem

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Weight loss
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Renal System
    • Symptom - Anuria
  • Gastrointestinal System
    • Symptom - Constipation
  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking

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 28-Apr-2021, an 11 year old, approximately 5 pound, neutered, female, Domestic Longhair cat, in unknown condition, with no known concomitant medical conditions, was administered 1 collar of Hartz UltraGuard Plus Flea and Tick Collar for Cats and Kittens (Tetrachlorvinphos (Rabon) / S Methoprene) via the topical route by the animal owner. The product was also administered to four other cats within the household the same day. On 05-May-2021, the cat developed lethargy, weight loss, anorexia, was unable to urinate and defecate, and was unable to rise and walk (recumbent). That same day, two other cats developed anorexia and weight loss and another two cats developed application site burn, application site hair loss and application site scabbing. On approximately 07-May-2021, the collars were removed from all five cats and they were all bathed using an unknown amount of liquid dish detergent as directed by a veterinarian over the phone. On 12-May-2021, the cat died at home and was buried. The clinical signs of the remaining four cats improved slightly after collar removal and bathing. This was a first time use of the product for all five cats. 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 has a wide margin of safety in cats when used per label directions. Even if ingested from the fur following use, only mild oral irritation or gastrointestinal upset resulting in drooling or vomiting would be expected. Signs did not occur in this case until 1 week after application and progressed even after the product was removed and the cat was bathed. The persistent signs described are not consistent with the toxicological profile of the product. Other causes including metabolic disease (kidney disease, diabetes, etc.), neoplasia (cancer), and severe flea bite anemia should considered in this case. Without diagnostics, the cause of death remains unknown. 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.