BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DILAPAN-S

    MDR report key: 772539 · Received October 15, 2006

    Report

    Report Number
    69597-2006-00001
    Event Type
    Injury
    Date Received
    October 15, 2006
    Report Date
    October 15, 2006
    Manufacturer
    GEL MED INTERNATIONAL
    Product Code
    MCR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOT KNOWN. I HAVE BEEN NAMED IN A LAWSUIT IN WHICH A PARTNER USED A DILAPAN AND IT APPARENTLY BROKE WITH A PIECE OF IT ENDING IN THE PERITONEAL CAVITY. THE CLAIM IS THAT THE DILAPAN CAUSED ADHESIONS, PAIN, ETC. IT WAS INSERTED PRIOR TO A D&C, AND IT WAS APPARENTLY FRAGMENTED AND WAS FOUND AT THE TIME OF SURGERY IN THE ABDOMINAL CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILAPAN-S DILAPAN, CERVICAL DILATOR MCR GEL MED INTERNATIONAL NOT KNOWN NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization NOT KNOWN.