FDA Adverse Event Malfunction Summary report: N

DORMIA STONE BASKET 4W W/O FILIFORM TIP

MDR report key: 22959 · Received May 24, 1995

Report

Report Number
2429473-1995-00013
Event Type
Malfunction
Date Received
May 24, 1995
Date of Event
April 4, 1995
Report Date
May 23, 1995
Manufacturer
PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE
Product Code
FFL
Product Problem
Yes
Report Source
Distributor report
Reporter Location
IL, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

THERE IS A PART MISSING THAT ALLOWS THE BASKET TO RETRACT BACK INTO THE SHEATH. RETURNED TO MFR FOR EVALUATION ON 5/1/95.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 DORMIA STONE BASKET 4W W/O FILIFORM TIP STONE BASKET FFL PORGES S.A. CENTRE D'AFFAIRES LA BOURSIDIERE 920101

Patients

Seq Age Sex Outcome Treatment
1 *