FDA Adverse Event
Malfunction
Summary report: N
CUSTOM EXTREMITY PACK
MDR report key: 20631850
·
Received November 6, 2024
Report
- Report Number
- MW5162309
- Event Type
- Malfunction
- Date Received
- November 6, 2024
- Date of Event
- October 28, 2024
- Report Date
- November 5, 2024
- Manufacturer
- AMERICAN CONTRACT SYSTEMS
- Product Code
- OJH
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
SPONGES WERE CONTAMINATED WITH WHAT APPEARED TO BE DIRT IN THE CUSTOM EXTREMITY PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1539494 | CUSTOM EXTREMITY PACK | ORTHOPEDIC TRAY | OJH | AMERICAN CONTRACT SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |