BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHELHIGH BOVINE GRAFT

    MDR report key: 247749 · Received October 29, 1999

    Report

    Report Number
    247749
    Event Type
    Other
    Date Received
    October 29, 1999
    Date of Event
    July 13, 1999
    Report Date
    October 29, 1999
    Manufacturer
    SHELHIGH, INC.
    Product Code
    FHK
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    RETURN TO SURGERY TO REMOVE BOVINE GRAFT. GRAFT APPEARED INFECTED. GRAFT WAS DISSOLVING RESULTING IN FAILED SLING (PUBO-VAGINAL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHELHIGH BOVINE GRAFT Implant BOVINE GRAFT FHK SHELHIGH, INC. 555-ORT-27 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other