BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE EXPANDER

    MDR report key: 23988 · Received February 21, 1995

    Report

    Report Number
    23988
    Event Type
    Injury
    Date Received
    February 21, 1995
    Date of Event
    January 20, 1995
    Report Date
    February 21, 1995
    Manufacturer
    MCGHAN MEDICAL CORP.
    Product Code
    LCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS 45-YR-OLD FEMALE UNDERWENT LEFT TOTAL MASTECTOMY ON 11/2/94 FOR BREAST CANCER, AND PLACEMENT OF A CO EXPANDER (600 CC FILL VOLUME) ON THE SAME DATE AS IMMEDIATE RECONSTRUCTION. SHE UNDERWENT FILLING OF THE EXPANDER IN THE PHYSICIAN'S OFFICE, AND BY MID-DECEMBER 1994, HAD COMPLETE FILLING OF THE EXPANDER. ON 1/18/95, SHE VISITED HER PHYSICIAN WHEN SHE NOTED A LESSENING OF THE FILL IN THE EXPANDER APPROX 1 WEEK AGO. THE PHYSICIAN ASSESSED AN OBVIOUS DEFLATION OF APPROX HALF THE VOLUME WHICH HAD PREVIOUSLY BEEN PRESENT IN THE EXPANDER. SHE WAS SCHEDULED FOR REMOVAL OF THE FAILED EXPANDER AND REPLACEMENT WITH A NEW EXPANDER FOR BREAST RECONSTRUCTION ON 1/20/95 AS A DAY SURGERY PROCEDURE. DURING THE SURGICAL PROCEDURE, THE SURGEON OBSERVED THE EXPANDER HAD ADHERED IN SEVERAL AREAS AND WAS REMOVED WITH DIGITAL MANIPULATION AND THEN THE EXPANDER WAS REMOVED. UPON REMOVAL THE SURGEON NOTED A PINHOLE IN THE EXPANDER IN THE UPPER POLE REGION. THE POCKET CONTAINED SOME CLEAR FLUID WHICH WAS LIKELY THE SALINE THAT HAD LEAKED FROM THE EXPANDER. ONCE THE AREA WAS COMPLETELY EVALUATED, A NEW CO BIOSPAN ANATOMICAL EXPANDER WAS PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE EXPANDER Implant TISSUE EXPANDER LCJ MCGHAN MEDICAL CORP. GR8561

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization