BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO QUADTRO SELECT HIGH PROFILE CUSHION

    MDR report key: 11631377 · Received April 7, 2021

    Report

    Report Number
    3008630266-2021-00007
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 7, 2021
    Report Date
    April 7, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED HE HAS A PRESSURE INJURY, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE CUSHION WAS RETURNED AND THE EVALUATION REPORT IS ATTACHED. ADDITIONAL CLARIFICATION: THE MATERIAL ON THE CUSHION CELL WAS FOLDED IN A WAY THAT ROHO, INC. COULD NOT REPRODUCE UNDER SIMULATED NORMAL USE. REPEATED FOLDING OF THE MATERIAL IN THIS MANNER LIKELY CAUSED THE CREASE WHICH LED TO THE FATIGUE FAILURE. IF ROHO, INC. BECOMES AWARE OF ADDITIONAL, RELEVANT INFORMATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER CALLED AND STATED: HE'S BEEN DEALING WITH MULTIPLE CUSHION FAILURES OVER THE LAST FEW YEARS. HE WAS USING A LOW PROFILE CUSHION AND RECENTLY CHANGED TO A HIGH PROFILE CUSHION RECENTLY PER RECOMMENDATION FROM HIS DEALER. ABOUT A YEAR AGO, HE ORDERED A NEW CUSHION AND IT WAS REPLACED IN (B)(6) 2020. THE REPLACEMENT CUSHION LEAKED AIR WHICH HE SAYS LED TO A BASEBALL SIZED PRESSURE INJURY THAT HAS OPENED UP. HE IS VERY ACTIVE, BUT EXPECTS TO SPEND A MONTH IN BED TO HEAL THE WOUND HE HAS NOT FOLLOWED UP WITH A DOCTOR, BUT IS BASING THAT ON HIS OWN PREVIOUS EXPERIENCES WITH INJURIES. HE MENTIONED THAT HE HAD CHECKED HIS CHAIR TO SEE IF ANYTHING WITH IT WAS CAUSING ISSUES FOR THE CUSHION. HE ALSO STATES THAT HE HAS NOTICED HIS CUSHIONS FAIL MORE FREQUENTLY SINCE HE STARTED USING HIS NEWER WHEELCHAIR, WHICH IS A QUICKIE GPV, RIGID. HE USES SIDE GUARDS WITH THE WHEELCHAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525842 ROHO QUADTRO SELECT HIGH PROFILE CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1010C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other