Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-6277

2. Registrant Information.

Registrant Reference Number: 2019-US-015731

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.

17-JUL-19

5. Location of incident.

Country: UNITED STATES

Prov / State: VIRGINIA

6. Date incident was first observed.

16-JUL-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)

---

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 %

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 1021-1723-2596

Product Name: Hartz UltraGuard Rid Flea and Tick Shampoo for Cats

• Active Ingredient(s)
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .479 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration .3 %
  • PYRETHRINS
    • Guarantee/concentration .15 %

---

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Unknown Flea and Tick Spot-on for Cats

• Active Ingredient(s)

---

7. b) Type of formulation.

Other (specify)

Collar, Shampoo, Spot-on

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?

No

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 )

0.4

7. Weight (provide a range if necessary )

Unknown

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 - Ataxia
  • Symptom - Seizure
  • Symptom - Unresponsive

• 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 approximately 14-Jul-2019 the pet owner bathed the cat using Hartz UltraGuard Rid Flea and Tick Shampoo for Cats (N-Octyl-Bicycloheptene Dicarboximide, Piperonyl Butoxide, Pyrethrins). The cat had a history of weight loss and flea infestation prior to product use. After bathing, the owner applied the Hartz UItraGuard Flea and Tick Collar for Cats (Tetrachlorvinphos) as well as an unknown spot-on product for cats (unknown active ingredient). On 16-Jul-2019 the cat developed ataxia and multiple seizures. The cat was unresponsive to the pet owner in between seizures. The signs continued that night until the cat died the morning of 17-Jul-2019. No veterinary intervention was sought due to financial concerns.

---

To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

Assessment: The Hartz collar and shampoo products are considered to have a wide margin of safety in cats. It is unknown what spot-on product was also applied to the cat, making this case difficult to fully assess. These pesticidal products are not labeled for use in conjunction with other pesticides. However, concomitant use of the identifiable products is not expected to result in seizures and death. Other causes should also be considered including severe flea bite anemia (due to history of fleas and weight loss), exposure to a concentrated pyrethroid product labeled for use on dogs only, unknown infectious disease or trauma given the young age of the animal. 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.