BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAST PROSTHESIS

    MDR report key: 4749 · Received April 27, 1993

    Report

    Report Number
    4749
    Event Type
    Malfunction
    Date Received
    April 27, 1993
    Report Date
    April 2, 1993
    Manufacturer
    MCGHAN TEXTURE BREAST PROSTH.
    Product Code
    KCZ
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PROSTHESIS WAS REMOVED BECAUSE OF CAPSULE FORMATIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREAST PROSTHESIS NA KCZ MCGHAN TEXTURE BREAST PROSTH. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other