BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX ANT

    MDR report key: 4210684 · Received October 29, 2014

    Report

    Report Number
    2125050-2014-00423
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 29, 2014
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT. THE PATIENT WAS BLEEDING FROM THE GLUTEAL ARTERY, AN ISSUE THAT OCCURRED DURING THE MESH IMPLANT PROCEDURE AND RESOLVED AT THE TIME OF THE IMPLANT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT WAS IMPLANTED WITH RESTORELLE DIRECTFIX ANT MESH. LATER, DURING THE PROCEDURE, THE PATIENT EXPERIENCED BLEEDING FROM THE GLUTEAL ARTERY. THE SURGEON RECOGNIZED THE ISSUE PROMPTLY AND THE PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY FOR EMBOLIZATION; POST EMBOLIZATION THERE WAS NO FURTHER BLEEDING. THE ISSUE WAS RESOLVED AT THE TIME OF THE IMPLANT, NO FURTHER FOLLOW-UP WILL OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693665 RESTORELLE DIRECTFIX ANT SURGICAL MESH FTL COLOPLAST A/S 5014502400 3008778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other