FDA Adverse Event
Malfunction
Summary report: N
BONE COLLECTION KIT
MDR report key: 21967668
·
Received May 6, 2025
Report
- Report Number
- 21967668
- Event Type
- Malfunction
- Date Received
- May 6, 2025
- Date of Event
- April 22, 2025
- Report Date
- April 23, 2025
- Manufacturer
- CENTURION MEDICAL PRODUCTS CORPORATION
- Product Code
- PXO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- WI
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
8 BONE FLAP KITS DIDN'T HAVE ARWF NUMBERS THAT SHOULD HAVE MATCHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67536 | BONE COLLECTION KIT | BONE MARROW BIOPSY TRAY | PXO | CENTURION MEDICAL PRODUCTS CORPORATION | 2024120590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |