BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALINE FILLED TESTICULAR PROSTHESIS

    MDR report key: 1598916 · Received February 13, 2010

    Report

    Report Number
    2125050-2010-00004
    Event Type
    Malfunction
    Date Received
    February 13, 2010
    Date of Event
    November 6, 2009
    Report Date
    December 9, 2009
    Manufacturer
    COLOPLAST MANUFACTURING US LLC
    Product Code
    FAF
    PMA / PMN Number
    P020003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE TESTICULAR DEVICE WAS RECEIVED FOR EVALUATION. EVALUATION AND TESTING OF THE RETURNED COMPONENT REVEALED A SEPARATION BETWEEN THE MID LINE AND INJECTION PORT ON THE SHELL OF THE DEVICE. TESTING REVEALED THIS TO BE THE SITE OF LEAKAGE. MICROSCOPIC EXAMINATION REVEALED THE SURFACE OF THE SEPARATION TO HAVE A CENTRAL GROOVE INDICATING THAT AREA WAS IN CONTACT WITH A SMALL SHARP INSTRUMENT SUCH AS A NEEDLE. BECAUSE THIS COMPONENT WAS RELEASED ACCORDING TO MANUFACTURING AND QUALITY CONTROL PROCEDURES, QA CONCLUDED THAT THE OBSERVED INSTRUMENT DAMAGE ON THE TESTICULAR SHELL OCCURED SUBSEQUENT TO THE DEVICE PACKAGING BEING OPENED. AS THE DEVICE WAS NEVER IMPLANTED, QA CONCLUDED THAT INSTRUMENT DAMAGE MOST LIKELY OCCURRED DURING THE PREPPING PROCEDURE.

    Description of Event or Problem · 1

    DATE OF EVENT: (B)(6)2009. ACCORDING TO THE AVAILABLE INFORMATION, THIS SALINE TESTICULAR DEVICE WAS TO BE IMPLANTED ON (B)(6)2009 BUT WAS NOT DUE TO DEVICE HAD A HOLE IN IT WHEN OPENED. ADDITIONAL INFORMATION RECEIVED FROM THE TERRITORY MANAGER WHO WAS PRESENT AT THE SURGERY, INDICATED UPON FILLING THE DEVICE, SALINE BEGAN TO SHOOT OUT THROUGH WHAT APPEARED TO BE A SMALL HOLE. SURGEON CLAIMS HE DID NOT PUNCTURE THE IMPLANT WITH THE NEEDLE AND TM DID NOT WITNESS HIM DO SO. SURGERY WAS NOT DELAYED AS TM HAD A SECOND DEVICE OF THE APPROPRIATE SIZE IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALINE FILLED TESTICULAR PROSTHESIS TESTICULAR PROSTHESIS FAF COLOPLAST MANUFACTURING US LLC 450-1327 5720929

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention