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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3781

2. Registrant Information.

Registrant Reference Number: ProPharma Group case#: 1-44325940

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.

02-JUN-16

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

30-MAY-16

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. 2596-167

Product Name: HARTZ ULTRAGUARD TOPICAL FLEA&TICK PREV. FOR DOGS&PUPPIES 31-60 LBS

  • Active Ingredient(s)
    • ETOFENPROX
      • Guarantee/concentration 55 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 10 %

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).

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

40

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Bloody diarrhea
  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Other
    • Specify - Obstruction in his throat

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

1-44325940 - The reporter indicated his dog was exposed to an insecticidal spot-on product containing the active ingredients etofenprox, N-Octyl bicycloheptene dicarboximide, and piperonyl butoxide. The reporter applied the product to his 6-month-old, 40-pound, female, Labrador Retriever dog three days before initial contact with the registrant. The dog licked the area where the product was applied. Two days before initial contact with the registrant, the dog developed vomiting and bloody diarrhea. The reporter was advised that this is not an expected reaction to the product and to seek veterinary attention immediately as there may be an underlying cause for the symptoms. On follow-up one day after initial contact, the reporter stated the dog was taken to the veterinarian where it was revealed she had an obstruction in her throat. The dog passed away the night of initial contact with the registrant. 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