BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 2844836 · Received November 2, 2012

    Report

    Report Number
    1523530-2012-00028
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 3, 2012
    Report Date
    November 1, 2012
    Manufacturer
    MIDMARK CORP.
    Product Code
    GBB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE STAPLES HOLDING THE VINYL TO THE ARM BOARD WERE TOO LONG AND NOT TO SPECIFICATIONS. THIS ALLOWED PART OF THE STAPLE TO EXIT THE SIDE OF THE ARM BOARD INTO THE FOAM PADDING. OVER TIME THE VINYL WORE TO THE POINT THAT THE END OF THE STAPLE WAS ABLE TO CONTACT THE FACILITY STAFF.

    Description of Event or Problem · 1

    MALE PATIENT SCRATCHED HIS FOREARM ON PATIENT RIGHT HAND SIDE ARM PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIDMARK CHAIR, SURGICAL, AC-POWERED GBB MIDMARK CORP. 647-001

    Patients

    Seq Age Sex Outcome Treatment
    1