BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 1872641 · Received September 29, 2010

    Report

    Report Number
    2936999-2010-01222
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    July 22, 2010
    Report Date
    August 30, 2010
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    BZW
    PMA / PMN Number
    K914887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN. WE ARE FOLLOWING UP WITH THE FACILITY FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED ON 08/30/2010, (B)(4). IT WAS REPORTED THAT "DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD) PORTION OF A GASTRIC PACEMAKER IMPLANTATION CASE, THE TEMPERATURE PROBE OF THE ESOPHAGEAL STETHOSCOPE BECAME DISLODGED DISTALLY DOWN INTO THE STOMACH. UPON EXTRACTION OF THE TEMPERATURE PROBE, THE PROXIMAL TIP BECAME LODGED IN THE LEFT LATERAL WALL OF THE CERVICAL ESOPHAGUS JUST BELOW THE UPPER ESOPHAGEAL SPHINCTER. THE RETAINED TIP WAS REMOVED SUCCESSFULLY, BUT A SMALL LACERATION OF THE LEFT LATERAL CERVICAL ESOPHAGEAL WALL DID OCCUR." THE PATIENT'S STAY IN THE HOSPITAL WAS EXTENDED, SHE WAS GIVEN ADDITIONAL ANTIBIOTICS AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MALLINCKRODT ESOPHAGEAL STETHOSCOPE W/TEMP SENSO BZW COVIDIEN/FORMERLY TYCO HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R