BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCGHAN MEDICAL CORP

    MDR report key: 375912 · Received January 24, 2002

    Report

    Report Number
    MW1023988
    Event Type
    Injury
    Date Received
    January 24, 2002
    Date of Event
    December 27, 2001
    Report Date
    January 24, 2002
    Manufacturer
    MCGHAN MEDICAL CORP
    Product Code
    FWM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT IDENTIFIED MALFORMATION IN RIGHT BREAST WHICH HAD A BREAST IMPLANT INSERTED FOLLOWING A MASTECTOMY. THE BREAST IMPLANT WAS FOUND BY OBSERVATION TO HAVE A HOLE AT APPROXIMATELY 2CM BELOW THE VALVE. THE IMPLANT WAS INSERTED IN 2000 AND NO EXTERNAL OR INTERNAL EVENT WOULD WARRANT THIS CONDITION. ACCORDINGLY, IT IS LIKELY THE IMPLANT WAS FLAWED WHEN INSERTED. FURTHER INVESTIGATION IS WARRANTED INTO THE QUALITY CONTROL AND QUALITY ASSURANCE BY ALL HANDLING THE DEFECTIVE DEVICE. THE DEFECTIVE IMPLANT WAS REPLACED WITH ANOTHER MCGHAN BREAST IMPLANT. PT WAS OUT OF WORK ON FRIDAY AND RECUPERATED OVER THE WEEK-END. AS A DIRECT AND UNFORTUNATE RESULT OF THE SURGICAL PROCEDURE, PT SUSTAINED INJURY TO LEFT SHOULD WHICH WAS DIAGNOSED BY ORTHOPEDIC DR. THE ORTHOPEDIST PRESCRIBED AN ANTI-INFLAMMATORY AND PHYSICAL THERAPY TWICE A WEEK FOR ATLEAST A MONTH. THE DEFECTIVE DEVICE HAS ACCORDINGLY CAUSED A DISRUPTION IN PT'S ABILITY TO CONDUCT NORMAL FUNCTIONING IN LIFE.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/10/02: MAKING AN INFORMED DECISION INDICATES THAT IMPLANT DEFLATION IS KNOWN COMPLICATION FOLLOWING BREAST IMPLANT SURGERY. CAUSES OF DEFLATION INCLUDE DAMAGE BY SURGICAL INSTRUMENTS DURING SURGERY, OVERFILLING OR UNDERFILLING OF THE IMPLANT WITH SALINE SOLUTION, CAPSULAR CONTRACTURE, CLOSED CAPSULOTOMY, STRESSES SUCH AS TRAUMA OR INTENSE PHYSICAL MANIPULATION, EXCESSIVE MANIPULATION, EXCESSIVE COMPRESSION DURING MAMMOGRAPHIC IMAGING, UMBILICAL INCISION PLACEMENT, AND UNK/UNEXPLAINED REASONS. IT SHOULD BE UNDERSTOOD THAT BREAST IMPLANTS MAY WEAR OUT OVER TIME AND DEFLATE/RUPTURE. THE DEVICE ASSOCIATED WITH THIS EVENT HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE MCGHAN MEDICAL CANNOT PROVIDE A PROBABLE CAUSE TO THE REPORTED EVENT NOR CONFIRM THE COMMENT THAT THE "IMPLANT WAS FLAWED WHEN INSERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCGHAN MEDICAL CORP SALINE FILLED BREAST IMPLANT FWM MCGHAN MEDICAL CORP UNK LK6327

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| O| R| S RESULTED.| DEFECTIVE DEVICE AND REPLACE. INJURY TO SHOULDER| SURGERY REQUIRED, GENERAL ANESTHESIA TO REMOVE