BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCGHAN BREAST IMPLANT, 200 CC

    MDR report key: 6568 · Received September 28, 1993

    Report

    Report Number
    6568
    Event Type
    Malfunction
    Date Received
    September 28, 1993
    Date of Event
    June 10, 1993
    Report Date
    September 3, 1993
    Manufacturer
    MCGHAN GEL SINGLE LUMEN
    Product Code
    FTR
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BREAST IMPLANTS FAILED AND WERE REMOVED DURING SURGERY.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN BREAST IMPLANT, 200 CC Implant NA FTR MCGHAN GEL SINGLE LUMEN NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other