BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFANT TNCHOFF 2 CUFF

    MDR report key: 2023840 · Received March 14, 2011

    Report

    Report Number
    1317749-2011-00087
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    November 9, 2010
    Report Date
    February 21, 2011
    Manufacturer
    COVIDIEN
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A PERITONEAL DIALYSIS CATHETER. THE CUSTOMER STATES PEDIATRIC HOSP DID PERITONEAL DIALYSIS TREATMENT TO A CHILD. AFTER 3 WEEKS, THE CHILD RECOVERED AND DOCTOR TOOK OUT THE CATHETER AND THE CHILD LEFT HOSP. THE PT FOUND A BULGING IN THE ABDOMEN; THE LOCAL HOSP FOUND A FOREIGN MATTER IN THE CHILD'S BODY ON (B)(6) 2010. THE FOREIGN MATTER WAS RESIDUAL OF THE PERITONEAL DIALYSIS CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT TNCHOFF 2 CUFF PERITIONEAL DIALYSIS CATHETER FJS COVIDIEN 8888414227 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK