BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RUGEL (BARD/DAVOL)

    MDR report key: 636417 · Received September 14, 2005

    Report

    Report Number
    636417
    Event Type
    Injury
    Date Received
    September 14, 2005
    Date of Event
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    DAVOL
    Product Code
    FTL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD ATTEMPTED LAPAROSCOPY OPEN VENTRAL HERNIA REPAIR WITH MESH IN 07/2005. PATIENT RETURNED TO PHYSICIAN'S OFFICE IN 09/2005 WITH POSSIBLE INFECTED MESH. PATIENT HAD SURGERY NEXT DAY FOR LAPAROTOMY - REMOVAL MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUGEL (BARD/DAVOL) MESH PROSTHESIS X2. FTL DAVOL 0010205 43BPD325(BOTH HAD SAME LOT# )

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization