FDA Adverse Event
Malfunction
Summary report: N
DISC SHAVER
MDR report key: 15506352
·
Received September 29, 2022
Report
- Report Number
- 3009051471-2017-00008
- Event Type
- Malfunction
- Date Received
- September 29, 2022
- Date of Event
- July 25, 2017
- Report Date
- September 28, 2022
- Manufacturer
- CTL MEDICAL CORPORATION
- Product Code
- QLQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
DISC SHAVER DISCONNECTED BETWEEN PROXIMAL AND DISTAL END.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1748063 | DISC SHAVER | QLQ | CTL MEDICAL CORPORATION | 103.7110 | 15ES.SBBB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |