BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX COMP STOMY 15CM HOLE 35MM X1

    MDR report key: 1971470 · Received January 19, 2011

    Report

    Report Number
    2647580-2010-01021
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    November 4, 2010
    Report Date
    December 3, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    FTL
    PMA / PMN Number
    K081126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: HERNIA. ACCORDING TO THE REPORTER: THREE DAYS POST-OPERATIVELY IT WAS NOTICED THAT THE BOWEL WAS PERFORATED AND A LAPAROTOMY WAS NECESSARY. ALLEGEDLY, THE HYDROGEL COATING WAS SEPARATED FROM THE MESH AND LAY ON THE BOWEL. IT WAS GLUED WITH THE BOWEL AND IT WAS DISSECTED OFF EXTENSIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARIETEX COMP STOMY 15CM HOLE 35MM X1 PARIETEX COMPOSITE MESH FTL USSC PUERTO RICO PJD00334

    Patients

    Seq Age Sex Outcome Treatment
    1 Other