BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPONGE, BICOL, (COLLAGEN)

    MDR report key: 2020267 · Received March 11, 2011

    Report

    Report Number
    1226348-2011-00108
    Event Type
    Other
    Date Received
    March 11, 2011
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    EFQ
    PMA / PMN Number
    PREAMEND
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS COMMUNICATED THAT THE DEVICE AND/OR LOT NUMBER IS NOT AVAILABLE FOR INVESTIGATION. ADDITIONALLY, THERE WAS NO PRODUCT PROBLEM REPORTED. THE INSTRUCTIONS FOR USE CLEARLY INDICATE, UNDER WARNINGS AND PRECAUTIONS THAT THE DEVICE SHOULD NOT BE LEFT IN THE SITU. THE COMMENTS PROVIDED BY THE SURGEON WERE BASED ON USER PREFERENCE. THIS IS CONSIDERED TO BE AN ISOLATED EVENT. THIS IS THE FIRST COMPLAINT OF THIS KIND FOR THIS PRODUCT REPORTED. BASED ON THE RESULTS OF THIS INFO, NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT BICOL SPONGE WAS MISTAKEN FOR DURAGEN DURAL SUBSTITUTE AND ALMOST LEFT IN THE BRAIN. AS A RESULT, THE SURGERY WAS DELAYED AS THEY HAD TO REMOVE THE BONE FLAP TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPONGE, BICOL, (COLLAGEN) CODMAN BICOL SPONGE EFQ CODMAN & SHURTLEFF, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention