BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLAMEND

    MDR report key: 1212103 · Received October 24, 2008

    Report

    Report Number
    1213643-2008-00468
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    May 15, 2008
    Report Date
    September 26, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTM
    PMA / PMN Number
    K052322
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT REPORT OF INFECTION, (MRSA AND E. COLI), WITH OPEN, TUNNELED WOUND THAT HAS REQUIRED ANTIBIOTICS, HOSPITALIZATIONS, AND 5 SURGICAL DEBRIDEMENTS WITH PARTIAL EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLAMEND FTM DAVOL INC., SUB. C.R. BARD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R