BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE DEVILBISS HEALTHCARE APP SYS,DLX,VARIABLE PRESSURE

    MDR report key: 24071244 · Received January 14, 2026

    Report

    Report Number
    2438477-2026-00001
    Event Type
    Injury
    Date Received
    January 14, 2026
    Date of Event
    December 21, 2025
    Report Date
    April 3, 2026
    Manufacturer
    GRAND HEALTHCARE CO. LTD
    Product Code
    FMW
    UDI-DI
    00822383534411
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DRIVE DEVILBISS HEALTHCARE INCORRECTLY REPORTED THE DEVICE AS A BARIATRIC MATTRESS, PRODUCT NUMBER 15301 AND SERIAL NUMBER (B)(6). THE CORRECT DEVICE IS APP SYS, DLX,VARIABLE PRESSURE, PRODUCT NUMBER 14001E, SERIAL NUMBER UNKNOWN. THE DEVICE IS NOT RETURNING FOR EVALUATION. THE END USER HAS DISCARDED THE DEVICE. THE CORRECT MANUFACTURER FOR PRODUCT NUMBER 14001E IS GRAND HEALTHCARE CO. LTD. 4F, NO.49, SEC.2, JEN AI ROAD TAIPEI, TW. THIS HAS BEEN UPDATED IN SECTION D1, D3,D4 AND F14.

    Additional Manufacturer Narrative · 0

    DRIVE DEVILBISS HEALTHCARE RECEIVED ADDITIONAL INFORMATION INDICATING THAT THE END USER REQUIRED PRESCRIPTION MEDICATION AS PART OF THEIR WOUND CARE MANAGEMENT. DURING THE REVIEW OF MDR 2438477-2026-00001, IT WAS IDENTIFIED THAT THE MANUFACTURER ADDRESS DOCUMENTED IN THE REPORT WAS INCORRECT. THE CORRECT MANUFACTURER ADDRESS IS AS FOLLOWS: POLIURETANOS SA DE CV ALFREDO NOBEL S/N ZONA INDUSTRIAL TOLUCA, MÉXICO 50010, MEXICO. SECTIONS D3 AND F14 OF THE MDR HAVE BEEN UPDATED TO REFLECT THE ACCURATE MANUFACTURER ADDRESS.

    Description of Event or Problem · 0

    DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A BARIATRIC MATTRESS. THE END USER REPORTED THAT THE MATTRESS HAS FAILED ON THREE OCCASIONS BY "BOTTOMING OUT," WHICH RESULTED IN THE DEVELOPMENT OF BED SORES REQUIRING HOME HEALTH WOUND CARE. ATTEMPTS TO GATHER ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127008 DRIVE DEVILBISS HEALTHCARE APP SYS,DLX,VARIABLE PRESSURE COVER, MATTRESS (MEDICAL PURPOSES) FMW GRAND HEALTHCARE CO. LTD 14004E 00822383534411

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention