BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE

    MDR report key: 20273244 · Received September 20, 2024

    Report

    Report Number
    2438477-2024-00049
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    July 12, 2024
    Report Date
    September 20, 2024
    Manufacturer
    APEX MEDICAL CORP
    Product Code
    FNM
    UDI-DI
    00822383565866
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    (B)(6) HEALTHCARE WAS NOTIFIED OF A COMPLAINT INVOLVING A PRESSURE PREVENTION MATTRESS, WHICH IS INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE MOTHER OF THE END-USER REPORTED THAT THE MATTRESS "HAD BEEN LOW FOR A WHILE" AND HAD NOTICED THIS WHEN ROTATING HIM IN THE BED. THE MOTHER INDICATED THAT THE TUBING HAD DISINTEGRATED WHERE IT ATTACHES TO THE PUMP, AND SHE TRIED TO FIX IT BY USING CLAMPS AND DUCT TAPE. THE MOTHER REPORTED THAT HER SON DEVELOPED A NEW PRESSURE SORE IN THE GROIN AREA THAT IS REQUIRING DEBRIDEMENT. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, (B)(6) HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471322 DRIVE DEVILBISS HEALTHCARE MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM APEX MEDICAL CORP 14200 00822383565866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other