BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROHO CONTOUR SELECT CUSHION

    MDR report key: 24230087 · Received February 2, 2026

    Report

    Report Number
    3008630266-2026-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    January 8, 2026
    Report Date
    January 31, 2026
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    UDI-DI
    00613732077303
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INSPECTION OF THE CUSHION WAS PERFORMED ON 01/22/2026 AFTER RETURN. A TEAR WAS FOUND BETWEEN TWO CELLS WHICH WAS PRODUCING A SLOW LEAK. THE TEAR WAS LOCATED AT THE BASE BETWEEN TWO CELLS MAKING IT DIFFICULT TO SEE. THE TEAR WAS LOCATED IN A POSITION IN WHICH THE BACK OF THE CUSHION IS GLUED TO THE CELLULAR SURFACE OF THE CUSHION. EVERY CUSHION IS INSPECTED SEVERAL TIMES THROUGH THE MANUFACTURING PROCESS. ONE OF THE FINAL STEPS OF THE ASSEMBLY PROCESS IS TO OVER-INFLATE THE CUSHION AND HOLD THEM OVERNIGHT. FINAL INSPECTION OF THE OVER INFLATED CUSHIONS ARE PERFORMED TO ENSURE THE CUSHION HAS NOT DEFLATED DURING THE HOLDING PERIOD TO ENSURE NO UNOBSERVED LEAKS ARE PRESENT. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION THAT THIS PROCESS IDENTIFIED ANY DEFECTS. TEARS SUCH AS THE ONE OBSERVED IN THIS INVESTIGATION ARE CAUSED BY A PULLING/SHEARING PROCESS. THESE TEARS ARE OBSERVED DURING THE MANUFACTURING PROCESS DURING THE STEPS UP TO ASSEMBLY AND ARE CULLED OUT AT ALL STAGES OF THE MANUFACTURING PROCESS. THESE TEARS HAVE ALSO BEEN OBSERVED AFTER DELIVERY BY SHEARING FORCES ON THE CUSHION SUCH AS PULLING THE CUSHION BY A CELL, CARRYING THE CUSHION BY THE CELLS, IMPROPER TRANSFER TECHNIQUE ETC. ROHO WAS UNABLE TO RULE OUT THE POSSIBILITY THAT THIS TEAR WAS PRESENT PRIOR TO ASSEMBLY OF THE CUSHION. THE LOCATION OF THE TEAR COULD HAVE ALLOWED THE GLUED SURFACE TO SEAL THE TEAR FROM LEAKING, MASKING IT DURING THE FINAL INSPECTION PROCESS. THIS IS CONSIDERED AN ISOLATED INCIDENT AND NO FURTHER CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED TO THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    THE DEALER REPORTED THEIR USER HAS A CONTOUR SELECT CUSHION WHICH THE USER HAS COMPLAINED CONTINUES TO DEFLATE. THE DEALER HAS VISITED THE USER SEVERAL TIMES AND THE CUSHION APPEARED TO INFLATE PROPERLY AT EACH VISIT. AFTER THEIR VISIT THE RIGHT FRONT QUADRANT OF THE CUSHION DEFLATES. THE DEALER HAS BEEN UNABLE TO IDENTIFY A LEAK BUT THE USE HAS DEVELOPED A PRESSURE WOUND ON HIS BUTTOX WHICH HAS REQUIRED DAILY VISITS BY WOUND CARE FOR HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293470 ROHO CONTOUR SELECT CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. CS1211C 00613732077303

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other