BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 1050292 · Received May 22, 2008

    Report

    Report Number
    1213643-2008-00303
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    September 19, 2007
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS PROVIDED INDICATE THAT POST IMPLANT FOR THE PERFIX PLUG THE PT DEVELOPED A VENTRAL HERNIA. DURING THE PROCEDURE TO REPAIR THE VENTRAL HERNIA, IT WAS NOTED THAT THE PT HAD DENSE ADHESIONS FO THE SMALL BOWEL TO PREVIOUS MESH. DETAILS IN THE 09/19/2007 OPERATIVE REPORT DO NOT INDICATE ANY DEFECT OF THE MESH AND THE MESH WAS INSPECTED AND WAS NOT EXPLANTED. CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. WHILE RECURRENCE AND ADHESIONS ARE KNOWN ADVERSE EVENTS THAT ARE LISTED IN THE IFU, NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE WILL SUBMIT A FOLLOW UP REPORT WHEN/IF PRODUCT IS RETURNED FOR EVALUATION OR ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ATTORNEY'S REPORT OF PT'S ALLEGED SEVERE PAIN AND DURING A LAPAROSCOPIC SURGERY, THE SURGEON FOUND THE PERFIX PLUG TO BE DEFECTIVE AND ADHERED TO THE PT'S SMALL BOWEL. THE MESH WAS EXPLANTED. OPERATIVE REPORT FOR 2007 STATES FINDING AS "INCARCERATED VENTRAL HERNIA WITH DENSE ADHESION OF SMALL BOWEL TO PREVIOUS MESH." OPERATIVE PROCEDURE STATES THE SURGEON "FELT THAT THE MESH WAS ALREADY INCORPORATED AND WOULD CAUSE NO FURTHER DENSE ADHESIONS AND THEREFORE, THE CONGLOMERATE [BOWEL AND MESH] WAS DROPPED BACK TO THE ABDOMEN AND THE ABDOMEN WAS NOTED TO BE HEMOSTATIC"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA 43END183

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention