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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5626

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-27780136

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.

21-OCT-11

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

04-AUG-11

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. 2596-150

Product Name: UltraGuard Plus Flea Tick Drops Plus for Dogs Puppies Over 60 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 2.3 %
    • D-PHENOTHRIN
      • Guarantee/concentration 85.7 %

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

Pit Bull Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5

7. Weight (provide a range if necessary )

65

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Salivating excessively
  • General
    • Symptom - Hyperactivity
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Difficulty walking
  • Liver
    • Symptom - Hepatic failure
  • 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?

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

1-27780136-The reporter, a pet owner, indicated her animal was exposed to a topical insecticide containing the active ingredients phenothrin and methoprene. The pet owner indicated she had applied the product to her five year female sixty five pound pit bull dog three months prior to her initial contact with the registrant. The pet owner indicated later the same day of application she had noted her animal hyperactive, salivating excessively, loss of appetite, and unable to walk. The pet was brought to the veterinarian where blood work (non specific) was run. The pet owner stated she was told by the veterinarian the animal had lymphoma. The pet owner stated the animal improved following the initial incident. The pet owner indicated the product was applied to the animal again one month prior to her initial contact with the registrant. The pet owner indicated again within a few hours the animal demonstrated similar signs. The pet owner indicated the animal was again brought to the veterinarian where it was placed on an oral antibiotic for a suspected infection. The pet owner stated the animal died one month after application. The pet owner indicated the veterinarian had stated the animal died due to liver disease caused by the product. The animals remains were cremated without a necropsy. The pet owner was advised use of the product as labeled would not be expected to elicit the signs or out come seen. Liver disease lymphoma are inconsistent wit the toxicity profile of the active ingredient or the finished product. No further 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