FDA Adverse Event
Injury
Summary report: N
INDIANA TOME
MDR report key: 223275
·
Received May 12, 1999
Report
- Report Number
- 1825034-1999-00055
- Event Type
- Injury
- Date Received
- May 12, 1999
- Date of Event
- February 13, 1997
- Report Date
- May 11, 1999
- Manufacturer
- BIOMET, INC.
- Product Code
- EKD
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- ATTORNEY
Narratives
Description of Event or Problem · 1
CARPAL TUNNEL RELEASE PROCEDURE WAS PERFORMED ON 02/13/97 DURING WHICH INJURY TO THE MEDIAN NERVE WAS SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INDIANA TOME | INSTRUMENT, MANUAL, SURGICA | EKD | BIOMET, INC. | NA | 962640 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |