FDA Adverse Event
Injury
Summary report: N
CERAMO EJECTOR PUNCH
MDR report key: 13366615
·
Received January 26, 2022
Report
- Report Number
- MW5107005
- Event Type
- Injury
- Date Received
- January 26, 2022
- Date of Event
- January 17, 2022
- Report Date
- January 24, 2022
- Manufacturer
- FEHLING INSTRUMENTS, GMBH & CO. KG
- Product Code
- HAE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- SC, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A CERVICAL KERRISON BROKE DURING THE PROCEDURE WHILE IN USE. ALL PIECES WERE RETRIEVED BY SURGEON. FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1811290 | CERAMO EJECTOR PUNCH | RONGEUR, MANUAL | HAE | FEHLING INSTRUMENTS, GMBH & CO. KG | 8X17J543WM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |