BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMBU AURASTRAIGHT DISPOSABLE LARYNGEAL MASK

    MDR report key: 1690042 · Received May 13, 2010

    Report

    Report Number
    9610691-2010-00004
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    April 9, 2010
    Report Date
    May 12, 2010
    Manufacturer
    AMBU A/S
    Product Code
    BTM
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM WAS DISCARDED BY THE HOSP SO NO SAMPLE WAS RETURNED TO AMBU FOR EVAL. WE HAVE REVIEWED THE PRODUCTION RECORDS FOR THIS PRODUCT AND LOT AND DID NOT FIND ANY ABNORMALITY DURING PRODUCTION. IT WAS ALSO REPORTED BY THE HOSP THAT A SIMILAR PRODUCT (AMBU AURASTRAIGHT SIZE 4) WAS USED THE SAME DAY IN THE SAME FACILITY BY A DIFFERENT PROFESSIONAL WITHOUT ANY PROBLEMS. HOWEVER, AS PRODUCT WAS NOT RETURNED TO AMBU, IT IS NOT POSSIBLE TO CONCLUDE THE CAUSE OF THIS INCIDENT.

    Description of Event or Problem · 1

    PT'S UVULA WAS INJURED AS THE AURASTRAIGHT WAS REMOVED. PRODUCT WAS BEING USED DURING ROUTINE SURGERY. USER WAS A CRNA. THIS WAS THE FIRST TIME THE SITE USED AMBU'S AURASTRAIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBU AURASTRAIGHT DISPOSABLE LARYNGEAL MASK DISPOSABLE LARYNGEAL MASK BTM AMBU A/S AMBU AURASTRAIGHT 1120704

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other