BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR IMPLANT

    MDR report key: 1996586 · Received February 18, 2011

    Report

    Report Number
    1057129-2011-00007
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 19, 2011
    Report Date
    February 18, 2011
    Manufacturer
    POREX SURGICAL
    Product Code
    FWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MEDPOR LEFT HELICAL RIM IMPLANTS FROM THIS LOT WERE SOLD INTO COMMERCE. A DISTRIBUTOR THAT RECEIVED IMPLANTS FROM THIS LOT PROVIDED PICTURES OF THE IMPLANTS. WE CONFIRMED THAT THE IMPLANTS FROM THIS LOT WERE CORRECT FOR A MEDPOR LEFT HELICAL RIM IMPLANT. THE DEVICE HISTORY RECORDS WERE REVIEWED AND ALL PROCESSES AND TEST PARAMETERS WERE WITHIN THE MEDPOR IMPLANT SPECIFICATION. (B)(6)

    Description of Event or Problem · 1

    THE DOCTOR REPORTED TO THE DISTRIBUTOR THAT A MEDPOR LEFT HELICAL RIM IMPLANT WAS PURCHASED FOR AN UPCOMING SURGERY. THE DOCTOR REPORTED THAT WHILE IN SURGERY SHE OPENED THE PRODUCT AND FOUND A MEDPOR RIGHT HELICAL RIM IMPLANT INSIDE THE STERILE POUCH INSTEAD OF THE LEFT HELICAL RIM IMPLANT. THE DOCTOR REPORTED THAT THE SURGERY WAS ABLE TO BE COMPLETED BY MOLDING THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDPOR IMPLANT MEDPOR SURGICAL IMPLANT MATERIAL PREFORMED CRANIAL AND FACIAL IMPLANT FWP POREX SURGICAL NA F018C04

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization