BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2112321 · Received May 24, 2011

    Report

    Report Number
    1213643-2011-00238
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    May 2, 2011
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION. MEDICAL RECORDS PROVIDED WERE LIMITED TO THE OPERATIVE REPORT FROM (B)(6) 2009. BASED ON THIS INFORMATION, IT IS UNK WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONALLY, NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SEE MDR. 1213643-2011-00237 FOR INFORMATION RELATED TO THE OTHER PERFIX PLUG IMPLANTED ON (B)(6) 2009.

    Description of Event or Problem · 1

    PER PROVIDED MEDICAL RECORDS: (B)(6) 2009: PT WAS IMPLANTED WITH TWO PERFIX PLUGS DURING AN BILATERAL INGUINAL, LEFT INGUINAL LYMPHADENECTOMY. PER PT'S MOTHER: SINCE THE TIME OF IMPLANT, THE PT HAS EXPERIENCED SEVERE PAIN WHICH IS DESCRIBED TO RUNDOWN BOTH OF HIS LEGS. THE PT CAN NO LONGER SIT OR STAND FOR LONG PERIODS OF TIME. THIS IS REPORTED TO BE INTERFERING WITH THE PT'S ABILITY TO AMBULATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUSI0501

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Disability