BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES

    MDR report key: 2902267 · Received January 8, 2013

    Report

    Report Number
    1525712-2013-00196
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    UNKNOWN
    Product Code
    FMW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED. INJURY ALLEGED.

    Description of Event or Problem · 1

    (B)(4). INJURY ALLEGED. MALFUNCTION ALLEGED. RECEIVED A PHONE CALL FROM END USER'S DAUGHTER STATING IN THE PAST THEY PURCHASED A BED, MATTRESS AND THE PART ON TOP OF THE MATTRESS (PURCHASED 2ND HAND FROM SOMEONE WHOSE FAMILY MEMBER HAD EXPIRED) AND THAT IS THE AFFECTED PART THAT HAS CAUSED BED SORES TO HER MOTHER. MOTHER IS BEING TREATED BY WOUND CARE (NO FURTHER DETAILS). MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9393 MATTRESS COVER FOR MEDICAL PURPOSES 880.6190 FMW UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 86 Other