BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFIX PLUG

    MDR report key: 2120407 · Received June 3, 2011

    Report

    Report Number
    1213643-2011-00255
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 10, 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
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REVIEW OF THE OPERATIVE REPORT, THE PT HAD UNDERGONE REPAIR OF LEFT INGUINAL HERNIA IN (B)(6) OF 2007 AND HAD PERSISTENT PAIN AND POSSIBILITY OF A RECURRENT HERNIA IN (B)(6) 2011. THE OPERATIVE REPORT STATES "THERE WAS MARKED WEAKNESS IN THE POSTERIOR WALL OF THE INGUINAL CANAL AND THE PLUG HAD MIGRATED OUT OF THE INTERNAL RING, PULLING THE TISSUES ALONG WITH IT". THE OPERATIVE REPORT DOES NOT INDICATE A DEVICE FAILURE AS CAUSING OR CONTRIBUTING TO THE REPORTED EVENT AND RECURRENCE IS NOTED AS A POSSIBLE ADVERSE REACTION IN THE PRODUCT'S INSTRUCTIONS FOR USE. BASED ON THE INFO PROVIDED IT IS UNCLEAR IF THE DEVICE CONTRIBUTED TO THE REPORTED EVENT. A DHR REVIEW HAS BEEN CONDUCTED. ALL PAPERWORK APPEARED COMPLETE AND ACCURATE.

    Description of Event or Problem · 1

    PT REPORTED: ON (B)(6) 2007, PT UNDERWENT MESH IMPLANT. THE PT REPORTED CONSTANT PAIN AND SUFFERING. ON (B)(6) 2011, THE MESH WAS EXPLANTED. PER PROVIDED MEDICAL RECORDS: ON (B)(6) 2011, "THIS PT HAD PREVIOUSLY UNDERGONE REPAIR OF THE LEFT INGUINAL HERNIA IN 2007 AND NOW HAS PERSISTENT PAIN AND POSSIBLY A RECURRENT HERNIA." "WE FOUND THAT ALONG THE MEDIAL ASPECT THE MESH HAD REALLY SHRUNK AND THERE WAS A MARKED WEAKNESS IN THE POSTERIOR WALL OF THE INGUINAL CANAL AND ALSO THE PLUG HAD MIGRATED OUT OF THE INTERNAL RING, PULLING THE TISSUES ALONG WITH IT. AFTER CAREFUL DISSECTION, THE MESH WAS COMPLETELY REMOVED AND ALSO THE PLUG." ANOTHER MFR'S MESH WAS IMPLANTED. A JP DRAIN WAS PLACED. THE SKIN WAS CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFIX PLUG FTL DAVOL INC., SUB. C.R. BARD, INC. NA HURE3254

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention