BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURI-T REPLACEMENT

    MDR report key: 781640 · Received November 15, 2006

    Report

    Report Number
    6000048-2006-00597
    Event Type
    Injury
    Date Received
    November 15, 2006
    Date of Event
    October 27, 2006
    Report Date
    October 30, 2006
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    KNT
    PMA / PMN Number
    k961345
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN REC'D BY THE MFR. HOWEVER, AN EVAL HAS NOT YET BEEN PERFORMED THEREFORE A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP, THAT DURING A ROUTINE REPLACEMENT PROCEDURE OF AN ENTERAL FEEDING DEVICE (PT GENDER AND AGE UNK), SECURI-T REPLACEMENT, IN 2006, THE BOLSTER DETACHED FROM THE DEVICE. THE PHYSICIAN REMOVED THE BOLSTER WITH THE AID OF AN ENDOSCOPE AND ANOTHER DEVICE WAS PLACED. THE PT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SECURI-T REPLACEMENT KNT KNT BOSTON SCIENTIFIC M00568151 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention