BEUDAMED
    FDA Adverse Event Death Summary report: Y

    ROHO® LOW PROFILE® SINGLE COMPARTMENT CUSHION

    MDR report key: 16941165 · Received May 16, 2023

    Report

    Report Number
    3008630266-2023-00007
    Event Type
    Death
    Date Received
    May 16, 2023
    Date of Event
    April 8, 2023
    Report Date
    May 16, 2023
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    USER FACILITY AND VOLUNTARY MDR REPORTS WERE SENT TO FDA FOR DEATH OF A PATIENT USING A ROHO CUSHION (MW5117036 & 3351970000-2023-0001). EXPIRED RESIDENT HAD FALLEN OFF SIDE OF WHEELCHAIR. ROHO CUSHION SLID OVER THE EDGE OF POWER WHEELCHAIR AND WAS LODGED IN BETWEEN THE RESIDENT'S HEAD AND SEAT OF WHEELCHAIR. RESIDENT'S HEAD WAS PRESSED AGAINST ARM REST OF WHEELCHAIR. MEDICAL EXAMINER DEEMED CAUSE OF DEATH TO BE NATURAL CAUSES. ADMINISTRATOR OF REPORTING FACILITY WAS CONTACTED AND CONFIRMED EVENT BUT WAS UNABLE TO PROVIDE PATIENT DETAILS. THE USER HAS DIRECTION IN THE MANUAL TO: "MAKE SURE THAT THE NON-SKID BOTTOM OF THE CUSHION COVER FACES AWAY FROM THE INDIVIDUAL. USE DIRECTIONAL LABELS ON THE CUSHION AND ON THE COVER TO ORIENT THE CUSHION. WHEN POSSIBLE, USE HOOK AND LOOP FASTENERS TO FURTHER SECURE THE CUSHION TO THE WHEELCHAIR. HOOK FASTENERS ARE AVAILABLE UPON REQUEST." THE ORIGINAL CUSHION AND COVER WERE RETURNED AND AN EVALUATION REPORT IS ATTACHED. NO PROBLEMS NOR DEFECTS WERE IDENTIFIED DURING CUSHION AND COVER EVALUATION. PERMOBIL DID NOT FIND EVIDENCE THAT THE CUSHION CAUSED OR CONTRIBUTED TO REPORTED DEATH. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    USER FACILITY AND VOLUNTARY MDR REPORTS WERE SUMITTED TO FDA FOR DEATH OF A PATIENT USING A ROHO CUSHION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2184283 ROHO® LOW PROFILE® SINGLE COMPARTMENT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. 1R99LPC

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death