FDA Adverse Event
Injury
Summary report: N
SLIMLINE EZ
MDR report key: 1210883
·
Received October 23, 2008
Report
- Report Number
- MW5008732
- Event Type
- Injury
- Date Received
- October 23, 2008
- Date of Event
- October 15, 2008
- Report Date
- October 23, 2008
- Manufacturer
- SLIMLINE EZ
- Product Code
- LNK
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DEVICE USED TO RETRIEVE (LEFT) KIDNEY STONE CALLED 200 LASER - SLIMLINE EZ, BROKE INTO 2 PIECES DURING PROCEDURE - BOTH PIECES RETRIEVED FROM THE PT IMMEDIATELY - NO PERMANENT HARM TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SLIMLINE EZ | DEVICE USED FOR KIDNEY STONES | LNK | SLIMLINE EZ | 78260708 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |