BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1103083 · Received August 8, 2008

    Report

    Report Number
    1213643-2008-00390
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    February 16, 2001
    Report Date
    July 11, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 ADDITIONAL INFO BECOMES AVAILABLE. NOTE: REPORT FROM ATTORNEY INDICATES THAT NO DR HAD ATTRIBUTED THE EVENT TO THE USE OF OR ANY DEFECT IN THE PERFIX PLUG.

    Description of Event or Problem · 1

    ATTORNEY REPORTED: IN 2001- THE PT UNDERWENT A LEFT INGUINAL HERNIA REPAIR PROCEDURE WITH IMPLANT OF A PERFIX PLUG. IN 2004- THE PT REPORTS INCARCERATED VENTRAL HERNIA. NINE DAYS LATER- THE PT REPORTS A PERFORATION OF THE TRANSVERSE COLON. IN THE SAME MONTH- THE PT REPORTS DIGESTIVE ELIMINATION DIFFICULTIES ACCOMPANIED BY SEVERE ABDOMINAL PAIN AND SUSPECTED RECURRENT HERNIAS. INFO PROVIDED INDICATES THAT NO DR HAS ATTRIBUTED THE ABOVE BODILY INJURIES TO THE USE OF OR ANY DEFECT IN 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 43IKD103

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening