FDA Adverse Event
Other
Summary report: N
UMANO MATTRESS
MDR report key: 20588165
·
Received October 31, 2024
Report
- Report Number
- MW5162038
- Event Type
- Other
- Date Received
- October 31, 2024
- Report Date
- October 17, 2024
- Manufacturer
- UMANO MEDICAL INC.
- Product Code
- FNL
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT SAFETY ALERT "UNDETECTED FLUID INGRESS AND EGRESS FROM INPATIENT AND OUTPATIENT MATTRESSES CAN LEAD TO HOSPITAL-ASSOCIATED INFECTIONS, PATIENT TISSUE DEGRADATION, AND/OR PATIENT DEATH". ALERT REQUIRED REPORTING. REF REPORTS: MW5162037, MW5162039, MW5162040.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49343 | UMANO MATTRESS | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | UMANO MEDICAL INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | HILLROM.| STRYKER.| UMANO. |