BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAFORM 3X3 SPONGE 5PK

    MDR report key: 1611853 · Received February 12, 2010

    Report

    Report Number
    1226348-2010-00035
    Event Type
    Injury
    Date Received
    February 12, 2010
    Date of Event
    December 22, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GXQ
    PMA / PMN Number
    K041518
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED, A REVIEW OF THE MFG RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVAL WILL REVEAL THAT THE DEVICE CONFORMED TO SPECS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND, THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT A COUPLE OF WEEKS AFTER THE PROCEDURE, THE PT WAS DIAGNOSED WITH CHEMICAL MENINGITIS. THE SURGEON IS NOT SURE HOW THE PT GOT IT. (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURAFORM 3X3 SPONGE 5PK DURA SUBSTITUTE GXQ CODMAN & SHURTLEFF, INC. NA HB627

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention