BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1053312 · Received May 23, 2008

    Report

    Report Number
    1213643-2008-00305
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    December 15, 2004
    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

    THE PT IS CLAIMING THAT THE EVENT IS RESULTING FROM THE PLUG MESH; HOWEVER, SHE ALSO INDICATES THAT NO DOCTOR HAS 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 REPORTS OF PT'S ALLEGED SEVERE PAIN AND RIGHT OVARY STUCK TO THE PELVIC CUP WHICH RESULTED IN THE OVARY TO BE REMOVED DUE TO IMPLANT 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 43DOD081

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention| S