BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAR-A-JECT

    MDR report key: 62161 · Received January 10, 1997

    Report

    Report Number
    62161
    Event Type
    Malfunction
    Date Received
    January 10, 1997
    Date of Event
    October 14, 1996
    Report Date
    October 16, 1996
    Manufacturer
    SHERIDAN CATH CORP
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BULGING OF ENDOTRACHEAL TUBE CUFF. HERNIATING OVER LUMEN. PT BECAME HYPOXIC. TUBE REMOVED AND REPLACED WITH DIFFERENT TUBE. OXYGEN ADMINISTERED. HYPOXEMIA RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAR-A-JECT LARYNGECTOMY TUBE BTR SHERIDAN CATH CORP * 021318

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other