BEUDAMED
    FDA Adverse Event Other Summary report: N

    WILSON FRAME

    MDR report key: 2853220 · Received December 15, 2010

    Report

    Report Number
    2921578-2010-00020
    Event Type
    Other
    Date Received
    December 15, 2010
    Date of Event
    November 3, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MIZUHO OSI
    Product Code
    JEA
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    WE CONTACTED THE HOSPITAL TO ASK ABOUT THE PT, THE INCIDENT AND IF THEY WERE USING THE FOAM CROSSBAR PROTECTOR ON THE FRAME. INITIALLY THEY WERE UNABLE TO ANSWER OUR QUESTIONS, BUT LATER RESPONDED THAT THEY DID USE THE COVERS. ADD'L QUESTIONS WERE ASKED IN REFERENCE TO THE PT, PROCEDURE, DATE, CO-MORBIDITIES, WAS AN EKG LEAD PLACED MID-CHEST AND IF THE PT WAS WEARING A BRACE POST PROCEDURE. WE ALSO REQUESTED THAT THE HOSPITAL BE RE-INSERVICED ON THE USE OF THE DEVICE. THE HOSPITAL DID NOT RESPOND. WE WILL CONTINUED TO REQUEST INFO AND REC'D NO ADD'L RESPONSES. THEREFORE, WE ARE CLOSING THIS COMPLAINT WITH THIS CUSTOMER AND WILL MONITOR FOR FUTURE CLAIMS.

    Description of Event or Problem · 1

    HOSPITAL CONTACTED MIZUHO OSI CONCERNING A PT COMPLAINT REGARDING SKIN INJURY AFTER SURGERY. THE COMPLAINT WAS THAT THERE WERE SCRATCH LIKE OR BURN LIKE AREAS MID CHEST POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WILSON FRAME OPERATING ROOM TABLE ACCESSORY JEA MIZUHO OSI 5319G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK