FDA Adverse Event
Malfunction
Summary report: N
CROWN FINE SURGICAL INSTRUMENTS, INC.
MDR report key: 16512545
·
Received March 9, 2023
Report
- Report Number
- 16512545
- Event Type
- Malfunction
- Date Received
- March 9, 2023
- Date of Event
- February 3, 2023
- Report Date
- February 21, 2023
- Manufacturer
- CROWN FINE SURGICAL INSTRUMENTS, INC.
- Product Code
- NBZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NV
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
DEVICE MALFUNCTION DURING USE. DEVICE BROKE REQUIRING MANUAL EXTRACTION FROM UMBILICAL CORD.
Description of Event or Problem · 0
DEVICE MALFUNCTION DURING USE. DEVICE BROKE REQUIRING MANUAL EXTRACTION FROM UMBILICAL CORD.
Description of Event or Problem · 0
DEVICE MALFUNCTION DURING USE. DEVICE BROKE REQUIRING MANUAL EXTRACTION FROM UMBILICAL CORD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 626695 | CROWN FINE SURGICAL INSTRUMENTS, INC. | SCISSORS, UMBILICAL | NBZ | CROWN FINE SURGICAL INSTRUMENTS, INC. | 1122 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male |