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 | * |