BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY RESTRAINT NET-NYLON

    MDR report key: 1386692 · Received March 19, 2009

    Report

    Report Number
    2020362-2009-00119
    Event Type
    Malfunction
    Date Received
    March 19, 2009
    Report Date
    February 19, 2009
    Manufacturer
    J. T. POSEY CO.
    Product Code
    FMQ
    PMA / PMN Number
    K963412
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER): STITCHING ON THE STRAP NETTING COMING APART. RESULTS (OTHER): THE STRAP ON THE TOP RIGHT-SIDE IS BROKEN. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON A POSEY RESTRAINT NET-NYLON MODEL 8115 THE STITCHING ON THE TOP STRAP NETTING IS COMING APART. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY RESTRAINT NET-NYLON FMQ J. T. POSEY CO. 8115 2004-07

    Patients

    Seq Age Sex Outcome Treatment
    1 NI