BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY PROSTHESIS

    MDR report key: 6824 · Received July 23, 1993

    Report

    Report Number
    6824
    Event Type
    Injury
    Date Received
    July 23, 1993
    Manufacturer
    MENTOR
    Product Code
    KCZ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LEFT BREAST PROSTHESIS LEAKING. SURGICAL REMOVED AND ANOTHER PROSTHESIS INSERTED.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAMMARY PROSTHESIS KCZ MENTOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention