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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-4703

2. Registrant Information.

Registrant Reference Number: Prosar 1-20075921

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-SEP-09

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW JERSEY

6. Date incident was first observed.

18-SEP-09

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 Pro Flea/Tick Drops Plus for Dogs/Puppies 4-15 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).

The product was applied to 3 dogs (all 14 years of age or older) on 09/16/2009. NOTE: This product is not labeled for use on aged dogs (defined by the company as older than 10 years of age).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Silky Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Respiratory System
    • Symptom - Shortness of breath
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Muscle weakness
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

13. Was medical treatment provided? Provide details in question 17.

No

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

1-20075921: A reporter (dog owner) called on 09/21/2009 to report the exposure of 3 dogs to a flea and tick product containing the active ingredients Phenothrin and Methoprene. According to the reporter, the product was applied to the dogs (all 14 years of age or older) on 09/16/2009. On 09/18/2009, Dog #1 (1st Subform III) developed shortness of breath, ataxia, and rear limb weakness. The other 2 dogs were asymptomatic. The reporter was advised that the signs described are not expected to be related to product use. The signs of pyrethrin overdose were discussed. A recommendation was made to bathe the dog in a non-insecticidal shampoo or hand dish soap and take the dog to the veterinarian for evaluation. On follow up on 09/22/2009, the reporter stated that Dog #1 died at home. She was not taken to the veterinarian, and the caller stated that her signs were present prior to product application but worsened on 09/18/2009. No further information was obtained. NOTE: This product is not labeled for use in aged dogs (defined by the company as older than 10 years of age).


To be determined by Registrant

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

Death

19. Provide supplemental information here