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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2008-3639

2. Registrant Information.

Registrant Reference Number: Prosar case 1-16090521

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.

01-MAY-08

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

01-MAY-08

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. 2724-504-2596

Product Name: UltraGuard Plus Drops for Cats 5 lbs and Over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

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 reporter applied the product to her cats about 4/28/08.

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

Cat / Chat

3. Breed

Unknown breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Symptom - Fasciculations
  • Gastrointestinal System
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Rapid breathing
    • Symptom - Laboured breathing
  • General
    • Symptom - Vocalizing
  • Eye
    • Symptom - Pupil dilation
  • Respiratory System
    • Symptom - Decreased pulmonary function
    • Specify - 40% of normal lung capacity on x-ray
  • Gastrointestinal System
    • Symptom - Bloating
    • Specify - Possible ascites on x-ray
  • General
    • Symptom - Death
  • 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?

Yes

14. b) How long was the animal hospitalized?

3

Hour(s) / Heure(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

1-16090521: The reporter called on 5/1/08 to report she had applied a topical flea and tick product containing the active ingredients Methoprene and Etofenprox to her 1 year old female cat about 3 days previously (4/28/08). The cat had then hidden such that they could not find her until the day of the call. By the time they found her, the cat had become recumbent, had muscle tremors, and had become anorexic. The reporter had already bathed the cat in dish soap but she had not improved. The safety profile of the product was discussed and a recommendation was made to seek veterinary care immediately. Company sponsored hair testing was also discussed. A follow-up call from the attending veterinarian was received the same day (4/28). The cat had presented to the clinic tachypneic with labored breathing, had dilated but reactive pupils, and was weak and vocalizing. The safety profile of the product was discussed, and a recommendation was made to provide supportive care and pursue additional diagnostics - respiratory problems would not be expected from product exposure. The attending veterinarian called back later in the day to report the cat had passed away. X-rays had showed severe respiratory compromise with only about 40% of normal lung capacity and possible ascites. The veterinarian suspected Feline Infectious Peritonitis (FIP). He also revealed the cat had been a feral rescue. The company sponsored necropsy program was discussed and the appropriate forms were faxed to the veterinarian. As of 5/6/08, the only results received had been Microbiology results which showed no growth on aerobic culture (source = thoracic cavity).


To be determined by Registrant

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

Death

19. Provide supplemental information here