BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA MOD FEM N/BEAD M/L LT

    MDR report key: 138039 · Received December 11, 1997

    Report

    Report Number
    2219689-1997-00713
    Event Type
    Malfunction
    Date Received
    December 11, 1997
    Report Date
    December 10, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COULD NOT BE PERFORMED. DEVICE NOT RETURNED TO HOWMEDICA RUTHERFORD.

    Description of Event or Problem · 1

    THE STERILE INNER PACK WAS HARD TO SEPARATE FROM THE NON-STERILE OUTER PACKAGE. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PATIENT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA MOD FEM N/BEAD M/L LT Implant IMPLANT HSA HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other