BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1053308 · Received May 23, 2008

    Report

    Report Number
    1213643-2008-00310
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    June 19, 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
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    PT IS CLAIMING THAT THE EVENT IS RESULTING FROM THE PLUG MESH, HOWEVER, HE ALSO INDICATES THAT NO DOCTOR HAD ATTRIBUTED THE EVENT TO THE IMPLANT OF THE MESH. 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 EVAL OR ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY REPORT OF PT'S ALLEGED SEVERE PAIN AND REQUIRED NERVE INJECTIONS DUE TO PLACEMENT OF THE PERFIX PLUG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43DND153

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other