BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFIX PLUG

    MDR report key: 2378664 · Received December 8, 2011

    Report

    Report Number
    1213643-2011-00731
    Event Type
    Death
    Date Received
    December 8, 2011
    Date of Event
    June 28, 2011
    Report Date
    November 14, 2011
    Manufacturer
    DAVOL INC
    Product Code
    FTL
    PMA / PMN Number
    K922916
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE CONTACTED THE INITIAL REPORTER TO REQUEST ADDITIONAL INFORMATION AND TO REQUEST RETURN OF THE DEVICE FOR EVALUATION. THIS MDR INCLUDED ALL PATIENT, EVENT AND DEVICE INFORMATION DAVOL HAS RECEIVED TO DATE. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE ALLEGED EVENT. THE PATIENT'S FAMILY ALLEGES THE PATIENT EXPIRED DUE TO SEPTIC SHOCK WITH COMPLICATIONS DUE TO A SMALL OBSTRUCTION SHOWING NECROSIS DUE TO ADHESION TO THE MESH. MEDICAL RECORDS, AUTOPSY REPORT AND A DEATH CERTIFICATE HAVE NOT BEEN PROVIDED AT THIS TIME. THE INFORMATION PROVIDED INDICATES THE PATIENT DEVELOPED ADHESIONS WHICH IS A KNOWN ADVERSE EVENT LISTED IN THE PRODUCT'S INSTRUCTIONS FOR USE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED INCLUDING A REVIEW OF STERILITY RECORDS AND THERE WAS NO EVIDENCE OF A MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. ADDITIONALLY, NO SAMPLE WAS RETURNED FOR EVALUATION. WITH THE CURRENTLY AVAILABLE INFORMATION, NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    BASED ON THE INFORMATION REPORTED BY (B)(6) VIA EMAIL TO BARD (B)(4): ON (B)(6) 2004 - PATIENT UNDERWENT BILATERAL MESH PLUG HERNIOPLASTY WITH PERFIX PLUG. ON (B)(6) 2011 - PATIENT WAS ADMITTED AND UNDERWENT EMERGENCY SURGERY. THE PERFIX PLUG IS ALLEGED TO HAVE MIGRATED AND STRANGULATED THE INTESTINE. ON (B)(6) 2011 - PATIENT EXPIRED. THE PATIENT'S FAMILY ALLEGES THE PATIENT EXPIRED DUE TO SEPTIC SHOCK WITH COMPLICATIONS DUE TO A SMALL OBSTRUCTION SHOWING NECROSIS DUE TO ADHESION TO MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC NA 43DOD130

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R