FDA Adverse Event
Injury
Summary report: N
KERRISON RONGEUR 4MM
MDR report key: 20687477
·
Received November 13, 2024
Report
- Report Number
- MW5162531
- Event Type
- Injury
- Date Received
- November 13, 2024
- Date of Event
- November 11, 2024
- Report Date
- November 12, 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 BROKE WHILE IN USE, ALL PIECES RETRIEVED, NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169156 | KERRISON RONGEUR 4MM | RONGEUR | HTX | LIFE INSTRUMENT CORP. | 860-0804-0 | 27114081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Male | Required Intervention |