FDA Adverse Event
Injury
Summary report: N
BD BARD PARKER
MDR report key: 1873122
·
Received October 15, 2010
Report
- Report Number
- 2649798-2010-00004
- Event Type
- Injury
- Date Received
- October 15, 2010
- Date of Event
- September 30, 2010
- Report Date
- October 15, 2010
- Manufacturer
- BD
- Product Code
- GES
- PMA / PMN Number
- PREAMEND
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A #11 SURGICAL BLADE WAS BROKEN OFF IN PT DURING A SHOULDER ARTHROSCOPY. AN OPEN PROCEDURE WAS REQUIRED TO RETRIEVE THE BLADE FRAGMENT THAT REMAINED IN THE PT'S SHOULDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD BARD PARKER | #11 STAINLESS STEEL SURGICAL BLADE | GES | BD | NA | 0134282 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |