BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYBRIDSELECT LOW AIR LOSS MATTRESS

    MDR report key: 1253354 · Received December 2, 2008

    Report

    Report Number
    1419507-2008-00001
    Event Type
    Injury
    Date Received
    December 2, 2008
    Report Date
    November 26, 2008
    Manufacturer
    ROHO, INC.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL NOTIFICATION OF THE ADVERSE EVENT CAME DIRECT FROM ENDUSER IN 2008. FROM CONVERSATIONS WITH HER, IT APPEARS THAT THE HYBRIDSELECT WAS OFFERED AS A TRIAL. WITHIN THE FIRST MONTH OF USE (2004) SHE SAID SHE STARTED GETTING SKIN BREAKDOWN ON HER FOOT & ASKED TO HAVE THE MATTRESS REMOVED. AS OF 2008, SHE WAS STILL ON THE MATTRESS. SHE BLAMED THE VENDOR. VARIOUS O.T.S, & THE REGIONAL MINISTRY OF HEALTH FOR THEIR NON-RESPONSE TO HER REPEATED REQUESTS. THE VENDOR IS NOT A DIRECT CUSTOMER OF ROHO'S. ROHO SELLS INTO OTHER COUNTRY VIA ADVANCED HEALTHCARE, ROHO'S EXCLUSIVE DISTRIBUTOR. ADVANCED HEALTHCARE WAS NOT AWARE OF THE ISSUE EITHER UNTIL CONTACTED THEM. AS OF THIS WRITING, THE CURRENT O.T., REP IS SCHEDULED TO MEET WITH OTHER HEALTHCARE OFFICIALS & WITH REPORTER TO ASSESS HER CARE NEEDS, PLUS REPORTEDLY SHE WILL RECEIVE A RIK MATTRESS THAT SHE HAS BEEN REQUESTING. ROHO HAS NO KNOWLEDGE OF WHY THIS PARTICULAR PRODUCT WAS PRESCRIBED FOR REPORTER, WHY IT WAS NOT REMOVED UPON HER REQUEST OVER A 4+ YR SPAN, THE QUALITY OF CARE RECEIVED (CURRENT O.T. PRO BONO POST 30 HRS OF CARE) OR WHY SHE IS NOT HOSPITALIZED FOR HER CURRENT PRESSURE SORE(S). WE DO KNOW THAT SHE HAS CLAIMED BREAKDOWN, BUT HAS BEEN ON THE SAME PRODUCT FOR OVER 4 YEARS. ROHO HAS BEEN UNABLE TO LOCATE ANY DOCUMENT OF A 'CUSTOM' ROHO DRY FLOATATION MATTRESS SECTION BEING ORDERED. WHY THIS WAS ORDERED AS A REPLACEMENT FOR THE CUSHION USED IN THE HEEL AREA IS ALSO UNKNOWN. THE HYBRIDSELECT DID NO MALFUNCTION AS EVIDENCED BY REPORTER'S CONTINUED USAGE & LACK OF ANY CLAIM THAT IT HAS MALFUNCTIONED. WITH TOTAL UNITS SOLD SINCE 2004, REPORTER'S ISSUE IS UNIQUE.

    Description of Event or Problem · 1

    FROM ENDUSER: RECEIVED IN HER HOUSE, ROHO HYBRIDSELECT POWERED MATTRESS (POWERED FLOTATION THERAPY BED) IN 2004. THAT MONTH, ASKED SUPPLIER, PG SURG MED TO REMOVE MATTRESS AS STARTED TO DEVELOP PRESSURE SORES ON RIGHT FOOT. STILL USING MATTRESS AS OF LAST COMMUNICATIONS 2008. POSSIBLE APPROX THREE MONTHS EARLIER. POSSIBLY IN THAT MONTH, A 'CUSTOM' ROHO DRY FLOATATION MATTRESS SECTION WAS ORDERED BY A O.T. TO USE IN PLACEMENT OF HYBRIDSELECT'S ROHO HIGH PROFILE CUSHION IN THE FOOT SECTION. REPORTER NOTED THAT THIS DID NOT FIT PROPERLY. SHE ASSESSES HER CURRENT PRESSURE SORES TO HER RIGHT FOOT SLIDING OFF OF THE CUSHION &/OPR MATTRESS SECTION IN FOOT AREA. FURTHER STATES THAT SHE MAY NEED TO HAVE HER FOOT & POSSIBLY LEG AMPUTATED. SHE HAS AT SOME POINT LOST HER BABY TOE. MORE INFORMATION CAN NOT BE OBTAINED FROM REPORTER(ENDUSER), AS SHE WANTS NO FURTHER COMMUNICATION W/US. IT APPEARS THAT ENDUSER HAS TRIED UNSUCCESSFULLY OVER PAST 4+ YEARS TO HAVE THE HYBRIDSELECT REMOVED & REPLACED W/ANOTHER MANUFACTURER'S MODEL. SHE STATES SHE HAS REPEATEDLY REQUESTED THIS OF THE VENDOR, PG SURG MED, OF VARIOUS O.T.'S ASSIGNED TO HER CARE, & THE HEALTH MINISTRY. FIRST KNOWLEDGE WE HAVE OF ENDUSER'S SITUATION CAME W/HER CALL OF APPROX THREE MONTHS LATER. ROHO SELLS VIA AN EXCLUSIVE ANOTHER COUNTRY'S DISTRIBUTOR, WHO SELLS TO PG SURG MED. THE FOLLOWING MONTH O.T. & OTHER HEALTH PROFESSIONALS SCHEDULED TO MEET WITH REPORTER TO ASSESS HER CONDITION AND NEEDS. REPORTEDLY NEW MATTRESS APPROVED BY MINISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYBRIDSELECT LOW AIR LOSS MATTRESS HYBRIDSELECT FNM ROHO, INC. SAHYBMATT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention| S