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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7631

2. Registrant Information.

Registrant Reference Number: ProPharma Group case:# 1-46067461

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.

27-OCT-16

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

27-OCT-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. 2596-153

Product Name: HARTZ ULTRAGUARD RID FLEA & TICK DOG SHAMPOO

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

7. b) Type of formulation.

Liquid

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Maltese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.92

7. Weight (provide a range if necessary )

5.5

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Vomiting
  • Nervous and Muscular Systems
    • Symptom - Abnormal gait
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors

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?

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

1-46067461 - The reporter, a pet owner, indicated her dog was exposed to an insecticidal shampoo containing the active ingredient D-phenothrin. One day before the day of initial contact with the registrant, the reporter bathed her 5.5-pound, 11-month-old, female Maltese dog with the product. During the bathing, the dog licked the water and immediately vomited. Within 45 minutes after bathing, the dog had ataxia, hyper-salivation and muscle tremors. The reporter bathed the dog again with an unknown shampoo and brought her to a veterinarian. The dog died after being at the veterinary clinic for 5 minutes. The reporter was told that this is not an expected reaction to the product. Necropsy was discussed with the reporter and the proper forms were faxed to the veterinary clinic. 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