BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1050286 · Received May 22, 2008

    Report

    Report Number
    1213643-2008-00298
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    June 11, 2003
    Report Date
    April 25, 2008
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    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 EVAL OR ADDITIONAL INFO BECOMES AVAILABLE. NOTE: SEE MDR 1213643-2008-00297.

    Description of Event or Problem · 1

    ATTORNEY'S REPORT OF PATIENT'S ALLEGED SEVERE PIAN IN GROIN/TESTICULAR REGION, SWELLING AND TENDERNESS AT THE SITE OF THE IMPLANTS AND PLUG EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43HLD112

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention