BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STORZ SILICONE BIT LINER

    MDR report key: 2526457 · Received April 5, 2012

    Report

    Report Number
    1920664-2012-00058
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 7, 2012
    Report Date
    March 7, 2012
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    KBN
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE FILED SHOULD THE DEVICE BECOME AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 1

    A REPORT FROM THE USER FACILITY REPORTED "THEY WERE USING THE MOUTH GAG WITH THE (B)(4) BITE LINER TO PERFORM A TONSIL AND ADENOIDECTOMY ON A (B)(6) FEMALE. AFTER COMPLETING THE PROCEDURE THEY NOTED ONE OF THE NIPPLES THAT KEEPS THE BITE LINER ATTACHED TO THE MOUTH GAG WAS MISSING. THEY TRIED DOING AN X-RAY TO LOCATE IT AS WELL AS A LARYNGOSCOPY AND COULD NOT FIND THE MISSING PIECE." ADDITIONAL INFO: THEY EXCAVATED AFTER THE SURGERY AND THEN NOTICED THE LINER PART WAS MISSING SO THEY HAD TO RE-INTUBATE THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STORZ SILICONE BIT LINER SILICONE BITE LINER KBN BAUSCH & LOMB, INC. N7545

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention