BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX STERILE FIELD POST

    MDR report key: 7136004 · Received December 20, 2017

    Report

    Report Number
    2523190-2017-00150
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    November 28, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 12/13/2017. THE DEVICE HISTORY RECORD FOR PRODUCT ID 10244 LOT CODE 171 MANUFACTURED ON 3/29/2017 SHOWED NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND NOR WERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH EITHER LOT &/OR WORK ORDER NUMBER. EVALUATION VERIFIED CUSTOMER INFORMATION AS VALID. CLAMP DOES NOT BUILD ENOUGH PRESSURE UP. ROOT CAUSE IS MOST LIKELY ACCELERATED WEAR AND TEAR.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE SUPPORT ARM MOVES WITH A SLIGHT FORCE WHILE IN LOCKED POSITION. NO HARM DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916022 OMNI-FLEX STERILE FIELD POST SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 171

    Patients

    Seq Age Sex Outcome Treatment
    1