BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARLEX MESH

    MDR report key: 955535 · Received November 28, 2007

    Report

    Report Number
    1213643-2007-00899
    Event Type
    Injury
    Date Received
    November 28, 2007
    Report Date
    November 6, 2007
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    PREAMENDME
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH PRODUCT CODE 0112650, LOT NUMBER 43LOD006 FOR AN INGUINAL HERNIA REPAIR IN 2005. PER PATIENT, MESH HAS CURLED UP AND YOU CAN SEE THAT IT HAS CURLED UP. SHE HAS SEEN 2 DOCTORS. THEY WILL NOT REMOVE THE MESH BECAUSE OF TISSUE GROWTH. ALSO ALLEGES THAT SHE HAS SUFFERED NERVE DAMAGE IN HER LEGS SINCE THE SURGERY AND BELIEVES THAT MESH IS PRESSING ON SOME NERVES. PATIENT HAS ALSO HAD INJECTIONS AT THE SITE FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARLEX MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43LOD006

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Disability