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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-5486

2. Registrant Information.

Registrant Reference Number: PROSAR Case # 1-23995293

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-SEP-10

5. Location of incident.

Country: UNITED STATES

Prov / State: MASSACHUSETTS

6. Date incident was first observed.

02-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. 2596-149

Product Name: UltraGuard Plus Flea TIck Dog Shampoo with Aloe

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .101 %
    • D-TRANS ALLETHRIN
      • Guarantee/concentration .109 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .154 %

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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Mixed Breed

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4

7. Weight (provide a range if necessary )

48

lbs

8. Route(s) of exposure

Skin

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 - Hypothermia
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Salivating excessively
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle tremors
  • Renal System
    • Symptom - Urinary incontinence
  • General
    • Symptom - Death
  • Liver
    • Symptom - Elevated liver enzymes
  • Nervous and Muscular Systems
    • Symptom - Fasciculations
    • Symptom - Depression
  • General
    • Symptom - Hesitancy to move
    • Specify - reluctance to walk

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?

Yes

14. b) How long was the animal hospitalized?

1

Day(s) / Jour(s)

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

1-23995293- The reporter, a veterinarian, called to indicate exposure of a patient he was treating to an insecticide that contains the active ingredient d-trans Allethrin, N-octyl bicycloheptene dicarboximide, (S)-Methoprene. The veterinarian indicates a four year forty eight pound male mixed breed dog had presented to him the morning of his initial contact with the registrant with the described signs of salivation, ataxia, hypothermia, and lethargy. The animal had been bathed with the product, a flea and tick shampoo, at some indeterminate time immediately preceding presentation. The animal had been bathed with a noninsecticidal shampoo prior to presentation by the pet owner in effort to remove the product. The veterinarian indicated the animal had a topical flea and tick pyrethroid product applied one and one half weeks prior to this described presentation, and according to the veterinarian the animal had a similar reaction. The veterinarian was unable to specify the product to which the animal had been previously exposed but indicated due to this previous response he believed the animal had some sort of unique sensitivity to the general class of insecticide. The veterinarian was advised this was an unexpected response to use of the product according to the label. He was advised to wash the animal additionally to remove any residues and offer supportive care for symptoms seen. On routine follow up the veterinarian clarified the signs seen on presentation as fasciculations, tremors, depression, reluctance to walk, hypothermia, lethargy, urinary incontinence, the animal still had fleas, and its serum chemistry showed a mild increase in ALP (248). The veterinarian had additionally bathed the animal and hospitalized it on intravenous fluids and methocarbamol for one day. The animal was given doxycycline for suspected Lyme disease and tramadol for discomfort. The animal was discharged to the owner due to the cost of care and the Lyme test reported to be normal. The animals symptoms persisted but the owner did not seek further care due to lack of resources. The typical onset and course of pyrethroid toxicity were described to the veterinarian, as were the treatments and prognosis. It was added that the case appeared inconsistent with pyrethroid toxicity, further diagnostics were recommended if resources permitted to uncover the cause of the animal¿s illness. On further follow up the veterinarian indicated the animal died at home. The reporter was informed of registrant supported necropsy. 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