FDA Adverse Event
Malfunction
Summary report: N
COVER, MATTRESS (MEDICAL PURPOSES)
MDR report key: 21081570
·
Received January 6, 2025
Report
- Report Number
- MW5164316
- Event Type
- Malfunction
- Date Received
- January 6, 2025
- Report Date
- December 31, 2024
- Manufacturer
- SEG-MAX/DERBY INDUSTRIES.
- Product Code
- FMW
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
COMPROMISED MATTRESS, POTENTIAL UNDETECTED FLUID INGRESS FROM INPATIENT/ OUTPATIENT MATTRESS PER (B)(6)) PATIENT SAFETY ALERT AL24-01; ALERT AND RECALLS ID: SR-46567. REF REPORT: MW5164315.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1347479 | COVER, MATTRESS (MEDICAL PURPOSES) | COVER, MATTRESS (MEDICAL PURPOSES) | FMW | SEG-MAX/DERBY INDUSTRIES. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |