BEUDAMED
    FDA Adverse Event Other Summary report: N

    STERILE DRAPE SLEEVES

    MDR report key: 1912833 · Received November 5, 2010

    Report

    Report Number
    3005677147-2010-00009
    Event Type
    Other
    Date Received
    November 5, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K011775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS A WRONG EXPIRATION DATE ON PRODUCT LABEL ERROR. THE SINGLE LABEL SHOWS A DIFFERENT USE BY DATE THAN THE 20-PACK-LABEL. THE DIFFERENCE IN THE USE BY DATES WAS ONE YEAR, AND THE PRODUCT WAS LABELED AS EXPIRING A YEAR EARLIER THAN IT ACTUALLY DID. BECAUSE THE PRODUCT USE BY DATE WAS EARLIER BY A YEAR, THERE WAS NO RISK TO PT HEALTH. THE PROBLEM WAS DISCOVERED PRIOR TO SURGERY AND A DIFFERENT LOT WAS IMMEDIATELY USED AS A REPLACEMENT. REVIEW OF OTHER SIMILAR PRODUCT, BUT WITH DIFFERENT LOT NUMBERS DID NOT SHOW THE SAME PROBLEM.

    Description of Event or Problem · 1

    DISTRIBUTOR QUALITY REP REPORTED TO FHC THAT TWO DIFFERENT USE BY DATES (UBD) APPEARED ON THE SAME LOT-NUMBERED PRODUCT. THE SINGLE LABEL SHOWS A DIFFERENT UBD THAN THE 20-PACK LABEL. THERE WAS NO SURGERY OR PT IMPACT AS THIS WAS DISCOVERED PRIOR TO SURGERY AND THE CASE PROCEEDED AS SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERILE DRAPE SLEEVES DRAPE SLEEVES HAW FHC, INC. 125186

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other MICROTARGETING DRIVE SYSTEM