Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-2331

2. Registrant Information.

Registrant Reference Number: 2019-US-030794 and 2019-US-030797 (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.

30-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

30-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. 2596-153

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

• Active Ingredient(s)
  • D-PHENOTHRIN
    • Guarantee/concentration .27 %

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7. b) Type of formulation.

Liquid

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.08

7. Weight (provide a range if necessary )

0.7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Unconsciousness

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

2

Hour(s) / Heure(s)

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-Oct-2019, five, 1 month old, 0.7 pound, unknown sex, Maine Coon cats, in unknown condition, with no known concomitant medical conditions, were bathed using an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin) by the animal owner. This was an extra label use as the product is not labeled for use on cats. Approximately two hours after bathing, all five cats developed loss of consciousness and were evaluated by a veterinarian and hospitalized. The veterinarian immediately bathed all five cats with unspecified liquid degreasing dish soap. Approximately two hours later, two cats died at the clinic after receiving unspecified treatments. Another cat died on 31-Oct-2019 at the clinic. The two remaining cats were transferred to an emergency veterinarian and received treatments of intravenous fluids and intravenous lipids of unspecified doses. An unknown amount of time later the pet owner requested to cease further treatment for the remaining two cats and brought them home. The status of those two cats is unknown (coded as major severity) and the treating veterinarian had not received any updates from the owner as of 11-Nov-2019. 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 was misused as it is not labeled for use on cats. The active ingredient in this product is present in low concentration and is used at times in insecticidal shampoos for cats. These cats were also below the labeled age for most insecticidal products for cats. It was not reported if any diagnostics or necropsy was performed so a specific cause of death is unknown. Although the product was misused, other causes should also be considered in this case including infectious disease, malnourishment, congenital conditions, and anemia related to possible fleas. 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 can not 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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Maine Coon

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

0.08

7. Weight (provide a range if necessary )

0.7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Unconsciousness

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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-Oct-2019, five, 1 month old, 0.7 pound, unknown sex, Maine Coon cats, in unknown condition, with no known concomitant medical conditions, were bathed using an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin) by the animal owner. This was an extra label use as the product is not labeled for use on cats. Approximately two hours after bathing, all five cats developed loss of consciousness and were evaluated by a veterinarian and hospitalized. The veterinarian immediately bathed all five cats with unspecified liquid degreasing dish soap. Approximately two hours later, two cats died at the clinic after receiving unspecified treatments. Another cat died on 31-Oct-2019 at the clinic. The two remaining cats were transferred to an emergency veterinarian and received treatments of intravenous fluids and intravenous lipids of unspecified doses. An unknown amount of time later the pet owner requested to cease further treatment for the remaining two cats and brought them home. The status of those two cats is unknown (coded as major severity) and the treating veterinarian had not received any updates from the owner as of 11-Nov-2019. 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 was misused as it is not labeled for use on cats. The active ingredient in this product is present in low concentration and is used at times in insecticidal shampoos for cats. These cats were also below the labeled age for most insecticidal products for cats. It was not reported if any diagnostics or necropsy was performed so a specific cause of death is unknown. Although the product was misused, other causes should also be considered in this case including infectious disease, malnourishment, congenital conditions, and anemia related to possible fleas. 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 can not 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

Maine Coon

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.08

7. Weight (provide a range if necessary )

0.7

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>2 hrs <=8 hrs / >2 h <=8 h

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Unconsciousness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

15. Outcome of the incident

Unknown/Inconnu

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-Oct-2019, five, 1 month old, 0.7 pound, unknown sex, Maine Coon cats, in unknown condition, with no known concomitant medical conditions, were bathed using an unknown amount of Hartz UltraGuard Rid Flea and Tick Shampoo for Dogs (Phenothrin) by the animal owner. This was an extra label use as the product is not labeled for use on cats. Approximately two hours after bathing, all five cats developed loss of consciousness and were evaluated by a veterinarian and hospitalized. The veterinarian immediately bathed all five cats with unspecified liquid degreasing dish soap. Approximately two hours later, two cats died at the clinic after receiving unspecified treatments. Another cat died on 31-Oct-2019 at the clinic. The two remaining cats were transferred to an emergency veterinarian and received treatments of intravenous fluids and intravenous lipids of unspecified doses. An unknown amount of time later the pet owner requested to cease further treatment for the remaining two cats and brought them home. The status of those two cats is unknown (coded as major severity) and the treating veterinarian had not received any updates from the owner as of 11-Nov-2019. 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

Major

19. Provide supplemental information here