BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES

    MDR report key: 2443336 · Received January 4, 2012

    Report

    Report Number
    1836161-2011-00005
    Event Type
    Malfunction
    Date Received
    January 4, 2012
    Date of Event
    August 23, 2011
    Report Date
    October 24, 2011
    Manufacturer
    ASPEN SURGICAL PRODUCTS
    Product Code
    GES
    PMA / PMN Number
    PREAMEND
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE COULD NOT BE EVALUATED AS IT WAS NOT RETURNED; NOR WERE ANY OTHER SURGICAL BLADES FROM THE MEDICAL FACILITY RETURNED. THE LOT NUMBER FOR THE DEVICE THAT REPORTEDLY FAILED IS UNK. WE ARE UNABLE TO DETERMINE MANUFACTURE DATE WITHOUT A LOT NUMBER. THE FAILURE IS ATYPICAL AND, WITHOUT NECESSARY INFO FOR A PROPER INVESTIGATION, THE TRUE ROOT CAUSE CANNOT BE DETERMINED. UF REPORT REFERENCE # (B)(4).

    Description of Event or Problem · 1

    UF REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPEN SURGICAL PRODUCTS - BARD PARKER BLADES BARD PARKER RIB BACK, #10, STERILE GES ASPEN SURGICAL PRODUCTS 371110 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *