BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX LIGHTWEIGHT MONOFILAMENT

    MDR report key: 2150486 · Received June 16, 2011

    Report

    Report Number
    9615742-2011-00056
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    January 15, 2010
    Report Date
    May 23, 2011
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K090858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: A MESH WAS PLACED IN 2010. (B)(6) MONTHS LATER IN 2011, THE PATIENT PRESENTED WITH A SUPERFICIAL ABSCESS AND CELLULITIS AT THE SITE OF THE ORIGINAL CHOLE INCISION. THE ABSCESS WAS DRAINED AND THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 3 DAYS THEN CONVERTED TO PRIMETHOPRIM/SULFA. APPROXIMATELY 3.5 WEEKS, A CT SCAN DEMONSTRATED A 2X0.9CM ABSCESS ANTERIOR TO THE MESH. THE PATIENT UNDERWENT A 7.5 HOUR SURGERY TO REMOVE THE INFECTED MESH, CULTURES WERE SENT AND SUBSEQUENTLY GROWN. THE SURGERY WAS COMPLICATED BY A PNEUMOTHORAX INTRA-OPERATIVELY NECESSITATING A CHEST TUBE INSERTION AND THE SURGERY WAS COMPLETED WITH INSERTION OF A BIOLOGIC MESH PORCINE. THE PATIENT WAS THEN TRANSFERRED TO THE INTENSIVE CARE UNIT AND SUBSEQUENTLY TRANSFERRED TO SUBACUTE REHABILITATION ONE WEEK POST OPERATIVELY FOR COMPLETION OF A 2 WEEK COURSE OF IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX LIGHTWEIGHT MONOFILAMENT PARIETEX MESH FTL SOFRADIM PRODUCTION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R