BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTO-CAM MARYLAND DISS MONO 5

    MDR report key: 2524950 · Received April 5, 2012

    Report

    Report Number
    2523190-2012-00036
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 19, 2012
    Report Date
    April 5, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    HTD
    PMA / PMN Number
    K932456
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC HERNIA REPAIR PERFORMED ON (B)(6) 2012, THE ROTO-CAM BECAME HOT IN THE MID SHAFT RESULTING IN A MINOR BURN WITHIN THE PT'S ABDOMINAL WALL. NO TREATMENT WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTO-CAM MARYLAND DISS MONO 5 DISSECTING FORCEPS AND HOOKS HTD INTEGRA YORK, PA INC. 81109117

    Patients

    Seq Age Sex Outcome Treatment
    1