BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVER, MATTRESS (MEDICAL PURPOSES)

    MDR report key: 21081548 · Received January 6, 2025

    Report

    Report Number
    MW5164315
    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 RELEVANT. REF REPORT: MW5164316.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347478 COVER, MATTRESS (MEDICAL PURPOSES) COVER, MATTRESS (MEDICAL PURPOSES) FMW SEG-MAX/DERBY INDUSTRIES.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown