Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-0462

2. Registrant Information.

Registrant Reference Number: 2019-US-028016

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.

16-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

16-OCT-19

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. 2596-139

Product Name: Hartz UltraGuard Pro Flea and Tick Collar

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

15

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• 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.

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 13-Oct-2019 the pet owner applied one Hartz UltraGuard Pro Flea and Tick collar (tetrachlorvinphos, s-methoprene) to the cat. On 16-Oct-2019 the cat suddenly collapsed and died. The product was applied to two other cats in the home that remained asymptomatic. Though the pet owner was interested in pursuing a necropsy it is unknown if one was completed. 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 is considered to have a wide margin of safety in cats. If a small amount of product was ingested, only minor oral irritation or gastrointestinal upset resulting in drooling of vomiting would be expected. Sudden onset of collapse and death are not expected and not likely due to product use. Other causes including unknown trauma, underlying cardiac disease and aortic thromboembolism (saddle thrombus) should 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.