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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-1172

2. Registrant Information.

Registrant Reference Number: PROSAR Case #: 1-25136903

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.

10-JAN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

27-SEP-10

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: Advanced Care 4 in 1 Flea Tick Drops Plus for Dogs 46-60 lbs

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-401-2596

Product Name: UltraGuard Plus Flea Tick Home Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .01 %
    • PERMETHRIN
      • Guarantee/concentration .28 %

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

Dalmatian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

60

lbs

8. Route(s) of exposure

Skin

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 - Nausea
    • Symptom - Vomiting
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Salivating excessively
    • Symptom - Weight loss
  • Renal System
    • Symptom - Renal failure
  • General
    • Symptom - Death

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

1-25136903- The reporter, a pet owner, indicates his animal had been exposed to two registrant products with active ingredients phenothrin/methoprene and permethrin/methoprene. The pet owner indicated the latter product was applied ┐┐┐off and on? around the animals kennel or crate as the animal was a show dog. The pet owner indicates he applied the phenothrin/methoprene product, a topical flea and tick drop, to his three year sixty pound male Dalmatian dog four months prior to his initial contact with the registrant. The pet owner indicated the animal demonstrated signs consistent with stomach upset (vomiting and drooling) the day following application. A few days after that point the pet owner indicates the animal refused food and was lethargic. Within two weeks the animal began to lose weight. The animal was brought to the veterinarian two to three weeks following application. The veterinarian drew blood and reported to the owner the animal┐┐┐s kidneys were damaged; in fact, the animal was in renal failure. The pet owner indicated the veterinarian had expressed the opinion that the animal had been poisoned. The pet owner indicated the animal died twenty days following application. The pet owner was advised when used as labeled the signs seen would not be expected. Further, the signs seen, diagnosis reached and out come of the case were inconsistent with the toxicity profile of the active ingredients. When ingestion or accidental overdosage is seen in domestic animals and altogether different spectrum of signs is expected, no primary renal assault would be seen. No other information is available regarding the case.


To be determined by Registrant

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

Death

19. Provide supplemental information here