BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL BLADE WITHIN CUSTOM PACK

    MDR report key: 2625936 · Received June 15, 2012

    Report

    Report Number
    1417592-2012-00046
    Event Type
    Other
    Date Received
    June 15, 2012
    Date of Event
    May 17, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL BLADE FROM A CUSTOM EXTREMITY PACK BROKE AS THE SURGEON MADE THE INITIAL CUT DURING A CARPAL TUNNEL PROCEDURE. THE BROKEN TIP WAS RETRIEVED WITHOUT INJURY TO THE PATIENT. THE BLADE WAS RETURNED TO US IN TWO PIECES. THIS IS A BD BLADE. WE HAVE RECEIVED NO OTHER SIMILAR CONCERNS FOR THIS BLADE. ASPEN SURGICAL PRODUCTS, INC. OWNS THIS PRODUCT LINE OF SURGICAL BLADES. THEY HAVE BEEN NOTIFIED OF THE INCIDENT AND THE SAMPLE IS BEING FORWARDED TO THEM FOR FURTHER REVIEW AND INVESTIGATION.

    Description of Event or Problem · 1

    SURGICAL BLADE BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL BLADE WITHIN CUSTOM PACK GES ASPEN SURGICAL PRODUCTS, INC. 0001816

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention