FDA Adverse Event
Malfunction
Summary report: N
CROWN FINE SURGICAL INSTRUMENTS, INC
MDR report key: 16663539
·
Received April 3, 2023
Report
- Report Number
- 16663539
- Event Type
- Malfunction
- Date Received
- April 3, 2023
- Date of Event
- January 17, 2023
- Report Date
- January 24, 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
WAS CONTACTED BY THE MOTHER-BABY UNIT REGARDING A BROKEN CORD CLAMP CUTTER. IT BROKE WHILE TRYING TO REMOVE THE CORD CLAMP OFF OF AN INFANT. PHOTOS AVAILABLE. THIS IS THE SECOND REPORT MADE WITHIN A MATTER OF MONTHS REGARDING THE CUTTER BREAKING.
Description of Event or Problem · 0
WAS CONTACTED BY THE MOTHER-BABY UNIT REGARDING A BROKEN CORD CLAMP CUTTER. IT BROKE WHILE TRYING TO REMOVE THE CORD CLAMP OFF OF AN INFANT. PHOTOS AVAILABLE. THIS IS THE SECOND REPORT MADE WITHIN A MATTER OF MONTHS REGARDING THE CUTTER BREAKING.
Description of Event or Problem · 0
WAS CONTACTED BY THE MOTHER-BABY UNIT REGARDING A BROKEN CORD CLAMP CUTTER. IT BROKE WHILE TRYING TO REMOVE THE CORD CLAMP OFF OF AN INFANT. PHOTOS AVAILABLE. THIS IS THE SECOND REPORT MADE WITHIN A MATTER OF MONTHS REGARDING THE CUTTER BREAKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535621 | CROWN FINE SURGICAL INSTRUMENTS, INC | SCISSORS, UMBILICAL | NBZ | CROWN FINE SURGICAL INSTRUMENTS, INC. | 3322 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |