BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE HERNIA SYSTEM MESH

    MDR report key: 4241337 · Received November 10, 2014

    Report

    Report Number
    2210968-2014-15539
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    November 5, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    FTL
    PMA / PMN Number
    K984220
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ON (B)(6) 2013 ALONG WITH CONCURRENT EXPLORATORY LAPAROTOMY, LYSIS OF ADHESIONS, REPAIR OF ENTEROTOMY DUE TO LARGE VENTRICLE HERNIA (13X15 CM). IT WAS REPORTED THAT PATIENT UNDERWENT LAPAROSCOPIC REPAIR OF VENTRAL HERNIA WITH VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A VENTRAL HERNIA PROCEDURE IN (B)(6) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PERIUMBILICAL PAIN AND BURNING PAIN IN HER BACK. IT WAS REPORTED THAT THE PATIENT UNDERWENT A PARTIAL MESH REMOVAL ON (B)(6) 2014 DUE TO MESH WAS FOUND TO BE EXTENSIVELY ADHERED TO THE SMALL INTESTINE AND ABDOMINAL WALL, AND WRAPPED AROUND THE BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723493 PROLENE HERNIA SYSTEM MESH FTL ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention