FDA Adverse Event
Injury
Summary report: N
2MM KERRISON RONGEUR
MDR report key: 20420314
·
Received October 9, 2024
Report
- Report Number
- MW5160940
- Event Type
- Injury
- Date Received
- October 9, 2024
- Date of Event
- October 2, 2024
- Report Date
- October 4, 2024
- Manufacturer
- LIFE INSTRUMENT CORP.
- Product Code
- HTX
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
KERRISON RONGEUR BROKEN DURING USE, ALL PIECES RETRIEVED, NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2568742 | 2MM KERRISON RONGEUR | RONGEUR | HTX | LIFE INSTRUMENT CORP. | 830-0802-0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Required Intervention |