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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-6683

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-54691695

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-NOV-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

14-NOV-18

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. 2596-84

Product Name: HARTZ ULTRAGUARD FLEA & TICK COLLAR FOR DOGS - WHITE COLLAR

  • Active Ingredient(s)
    • 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).

1-54691695 - The reporter indicated a topical insecticidal product manufactured by the registrant was also used on the dog, but was unable to provide any information as to exactly what the product was. The registrant does not recommend using more than one insecticidal product on a dog at one time.

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

Dog / Chien

3. Breed

Mixed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

8

7. Weight (provide a range if necessary )

16

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Lameness
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Laboured breathing

12. How long did the symptoms last?

Persisted until death

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

Unknown

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

1-54691695 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal collar containing the active ingredient tetrachlorvinphos. Five days before the day of initial contact with the registrant, the reporter applied the product to her 8-year-old, 16-pound, female, mixed breed dog. Within 72 hours of application, the reporter indicated the dog was lethargic, limping, not eating and had labored breathing, so the reporter bathed the dog. One day before the day of initial contact, the reporter found the dog dead. The reporter was advised this is not an expected reaction to normal product use. 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