BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECT FIX

    MDR report key: 3840687 · Received August 21, 2013

    Report

    Report Number
    2125050-2013-00137
    Event Type
    Injury
    Date Received
    August 21, 2013
    Report Date
    March 12, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K092207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    COLOPLAST HAS NOT BEEN PROVIDED ANY CORROBORATING EVIDENCE TO VERIFY THE INFORMATION CONTAINED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP MDR IS CREATED TO DOCUMENT CORRECTED INFORMATION. THE (2BO) RESTORELLE DIRECT FIX A WAS THE DEVICE IMPLANTED FOLLOWING THE REPORTED ISSUE, NO COMPLAINT OR HARM ON THE COLOPLAST RESTORELLE DEVICE.

    Description of Event or Problem · 1

    AS REPORTED TO COLOPLAST THOUGH NOT VERIFIED, PATIENT EXPERIENCED AN EXCISION OF MIDURETHRAL SLING FROM THE URETHROVESICAL JUNCTION AND POSTERIOR AND ANTERIOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407082 RESTORELLE DIRECT FIX SURGICAL MESH FTL COLOPLAST A/S 5013601400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other