BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFIX PLUG

    MDR report key: 2451028 · Received February 10, 2012

    Report

    Report Number
    1213643-2012-00088
    Event Type
    Death
    Date Received
    February 10, 2012
    Date of Event
    October 6, 2011
    Report Date
    January 11, 2012
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER MULTIPLE TIMES TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDES ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. A NOTIFICATION WAS RECEIVED FROM A BARD EMPLOYEE IN THE (B)(4) INDICATION IT IS UNKNOWN IF ADDITIONAL INFORMATION WILL BE FORTHCOMING. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE USER FACILITY ALLEGED THE PERFIX PLUG HAD FISTULATED INTO THE SMALL BOWEL REQUIRING ADHESIONS AND THE SMALL BOWEL TO BE RELEASED. MEDICAL RECORDS HAVE NOT BEEN PROVIDED AND IT IS UNKNOWN HOW THE PERFIX PLUG WAS FIXATED DURING THE IMPLANT. THE REPORT IS UNCLEAR AS TO IF THE PERFIX PLUG MIGRATED AS THE USER FACILITY REPORTED "DUE TO THE DESIGN OF THE MESH PLUG IT SEEMS TO MIGRATE INWARDS." ALTHOUGH MEDICAL RECORDS HAVE NOT BEEN PROVIDED, BOTH FISTULA FORMATION AND ADHESIONS ARE NOTED ADVERSE EVENTS IN THE PRODUCT'S INSTRUCTIONS FOR USE. ADDITIONALLY, IT IS UNKNOWN IF THE MESH WAS EXPLANTED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. HOWEVER, WITHOUT ADDITIONAL INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED BY THE USER FACILITY TO A DAVOL SALES REPRESENTATIVE VIA (B)(4): (B)(6) 2004 - THE PATIENT WAS FIRST OPERATED ON. ON (B)(6) 2005 - THE PATIENT WAS TREATED FOR A RECURRENCE AND A PERFIX PLUG WAS PLACED IN AN OPEN INGUINAL PROCEDURE. ON (B)(6) 2011 - THE PATIENT WAS ADMITTED. THE PERFIX PLUG HAD FISTULATED INTO THE SMALL BOWEL. ADHESIOLYSIS WAS PERFORMED AND THE SMALL BOWEL WAS RELEASED FROM THE PERFIX PLUG. ON (B)(6) 2011 - THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death| H| R