BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAMMARY EXPANDER

    MDR report key: 9300 · Received July 29, 1994

    Report

    Report Number
    9300
    Event Type
    Injury
    Date Received
    July 29, 1994
    Date of Event
    February 18, 1994
    Report Date
    July 19, 1994
    Manufacturer
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PLEASE BE ADVISED THAT ON 2/18/94, A 54 YEAR OLD HISPANIC FEMALE, STATUS POST RIGHT BREAST MASTECTOMY APPROXIMATELY TWO MONTHS AGO WITH INSERTION OF A TEXTURED 800-900 CC MAGNISTIE MAMMARY EXPANDER; PRESENTED WITH RUPTURED EXPANDER. THE PATIENT UNDERWENT RE-INSERTION OF RIGHT BREAST TISSUE EXPANDER AFTER RUPTURE.THE PATIENT TOLERATED THE PROCEDURE WELL AND LEFT THE OPERATING ROOM IN AWAKE AND ALERT CONDITION.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 EXPANDER UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention