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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6224

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-49693582

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.

13-SEP-17

5. Location of incident.

Country: UNITED STATES

Prov / State: WEST VIRGINIA

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. 2596-153

Product Name: HARTZ ULTRAGUARD RID FLEA & TICK SHAMPOO FOR DOGS WITH OATMEAL

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

7. b) Type of formulation.

Other (specify)

shampoo

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).

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

5

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

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Collapse
    • Symptom - Unconsciousness
    • Symptom - Muscle tremors
    • Symptom - Seizure
  • Eye
    • Symptom - Pinpoint pupils

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?

Unknown

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

1-49693582 - The reporter, a veterinarian, indicated a dog was exposed to insecticidal shampoo containing the active ingredient D-phenothrin. One day before the day of initial contact with the registrant, the reporter stated a 5-pound, 4-year-old, male, mixed breed dog had been bathed with the product. An unknown amount of time later, the dog collapsed, but then appeared to improve, based on the owners account. An unknown amount of time later, the dog presented to the reporter unconscious, having tremors and seizures and pin point pupils. The reporter indicated the dog did not respond to treatment and died in the clinic the day before the day of initial contact with the registrant. The reporter did not think the symptoms were from the product application. No additional information is available


To be determined by Registrant

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

Death

19. Provide supplemental information here