BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROHO QUADTRO SELECT HIGH PROFILE CUSHION

    MDR report key: 11448892 · Received March 9, 2021

    Report

    Report Number
    3008630266-2021-00003
    Event Type
    Injury
    Date Received
    March 9, 2021
    Date of Event
    January 3, 2021
    Report Date
    April 7, 2021
    Manufacturer
    ROHO, INC.
    Product Code
    KIC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER EMAILS ROHO, INC. AND STATES HE HAS A PRESSURE INJURY, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE CUSHION WAS RETURNED TO ROHO, INC. AND THE EVALUATION REPORT IS ATTACHED. ROHO, INC. HAD NOT BEEN ABLE TO DUPLICATE THE PROBLEM. IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING ADDITIONAL CONVERSATION WITH THE END USER, HE STATED: HE HAD SEEN A SURGEON IN ORDER TO REMOVE DEAD TISSUE FROM THE WOUND AND WAS RECEIVING DAILY NURSING CARE UNTIL HE HAD A VAC MACHINE PLACED ON THE WOUND. HE WILL SEE A SURGEON FOR FOLLOW UP, BUT WAS NEVER HOSPITALIZED FOR THE WOUND. HE STATED THAT THE WOUND WAS HEALING AND HAD DECREASED TO 5 CM DEEP AND TO 2 1/2 CM WIDE. THE CUSHION WAS ORDERED IN (B)(6) OF 2020 AND HE RECEIVED IT IN (B)(6), SO HE USED IT WITH NO ISSUES IN (B)(6) OF 2020. IT WAS ON (B)(6), 2021 THAT HIS CARER NOTICED IT HAD FULLY DEFLATED AS HE HAS NO FEELING SO WAS NOT ABLE TO TELL IT WAS DEFLATED HIMSELF AND IT WAS AT THAT TIME THAT THE CARER ALSO NOTICED THE INJURY. AT THAT TIME, THE END USER AND HIS WIFE BEGAN TO HAVE TO INFLATE THE CUSHION DAILY AND OFTEN NOTICED FULL DEFLATION WITHIN 3-4 HOURS. HE CONFIRMED THAT HE USED THE INFLATION PUMP THAT CAME WITH THE CUSHION AND THAT HE WOULD USE THE INFLATION PUMP TO CLOSE THE VALVE, BUT THEN CHECK THAT IT WAS TIGHTENED WITH HIS HAND. WHEN THE CUSHION ISSUE STARTED THAT IS WHEN HE NOTICED THAT THE VALVE WOULD TIGHTEN CLOSED, BUT THEN CLICK AND RE-OPEN WHICH IS WHEN HE BELIEVED IT WOULD START LEAKING. HE WOULD THEN RE-TIGHTEN THE VALVE AND TRY TO GET IT AS TIGHT AS HE COULD BEFORE IT GOT TO THE POINT WHERE IT WOULD "CLICK" AND RE-OPEN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER EMAILS ROHO, INC. AND STATES HE HAS A PRESSURE INJURY, BUT ROHO, INC. HAS NOT SEEN MEDICAL RECORDS TO CONFIRM THIS. THE CUSHION WAS NOT RETURNED TO ROHO, INC., SO AN EVALUATION COULD NOT BE PERFORMED. THE CUSHION OPERATION MANUAL INCLUDES SAFETY INFORMATION INCLUDING THE FOLLOWING: DO NOT USE A PRODUCT THAT IS UNDERINFLATED OR OVERINFLATED BECAUSE THE PRODUCT BENEFITS WILL BE REDUCED OR ELIMINATED, RESULTING IN AN INCREASED RISK TO SKIN AND OTHER SOFT TISSUE. CAREFULLY FOLLOW THE INSTRUCTIONS FOR INFLATION, PLACEMENT, AND HAD CHECK. IF THE PRODUCT DOES NOT APPEAR TO BE HOLDING AIR, OR IF YOU ARE NOT ABLE TO INFLATE OR DEFLATE THE PRODUCT, SEE "TROUBLESHOOTING". IMMEDIATELY CONTACT YOUR EQUIPMENT PROVIDER, DISTRIBUTOR, OR CUSTOMER SUPPORT IF THE PROBLEM PERSISTS. IF THE CUSHION IS RETURNED FOR EVALUATION OR IF ADDITIONAL INFORMATION IS PROVIDED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE END USER STATED THE CUSHION WAS NOT HOLDING ITS PRESSURE, AND NEEDS TO BE PUMPED EVERY DAY, SOMETIMES SEVERAL TIMES A DAY. THEY ALSO STATED THE INFLATION VALVE DEVICE IS CONSTRUCTED OF BLACK PLASTIC, AND WHEN IT GETS SCREWED CLOSED TIGHTLY, IT WILL ACTUALLY SCREW TO A POINT WHERE IT REOPENS AND THEN NEEDS TO BE SCREWED CLOSED AGAIN. THE END USER SAID THAT ON (B)(6), THE CUSHION DEFLATED, RIGHT AFTER IT WAS INFLATED, AND THEY SAT ON IT FOR 12 HOURS. THE END USER STATED THEY HAVE A PRESSURE WOUND UNDER THEIR IT BONE THAT IS 2 CM IN DIAMETER AND 4 CM DEEP. THEY ALSO STATED THE FOLLOWING: EVERY DAY SINCE (B)(6) 2021, THEY RECEIVE HOME VISITS FROM A WOUND CARE NURSE. THE MOST RECENT ASSESSMENT FROM THE NURSE WAS ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339908 ROHO QUADTRO SELECT HIGH PROFILE CUSHION WHEELCHAIR CUSHION KIC ROHO, INC. QS1011C

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other WHEELCHAIR| WHEELCHAIR