FDA Adverse Event
Injury
Summary report: N
3M AGEE CARPAL TUNNEL RELEASE SYSTEM
MDR report key: 249988
·
Received November 15, 1999
Report
- Report Number
- 2020601-1999-00001
- Event Type
- Injury
- Date Received
- November 15, 1999
- Date of Event
- November 4, 1998
- Report Date
- November 15, 1999
- Manufacturer
- MICROAIRE SURGICAL INSTRUMENTS
- Product Code
- HRX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
MEDIAN NERVE LACERATION DURING ENDOSCOPIC CARPAL TUNNEL RELEASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3M AGEE CARPAL TUNNEL RELEASE SYSTEM | INSTRUMENT TO RELEASE CARPAL LIGAMANT | HRX | MICROAIRE SURGICAL INSTRUMENTS | 81010 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Required Intervention| S | EXPLORE NERVE & REPAIR (11/9/98 TO UNK). |