BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACHEAL TUBE FIXATION DEVICE

    MDR report key: 3190786 · Received June 14, 2013

    Report

    Report Number
    2020362-2013-00268
    Event Type
    Injury
    Date Received
    June 14, 2013
    Report Date
    May 19, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    CBH
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PT SEX: UNK. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL AND HAS NOT BEEN RECEIVED. NOTE: MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO ABOUT THE PT AND PRODUCT STATUS. NOTE: THIS SUBMISSION IS BASED ON THE USER REPORTED ISSUE STATEMENT. THE PT AND PRODUCT STATUS IS UNK. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER (PT'S MOTHER) REPORTED THE SIZE OF THE PRODUCT IS NOT CONSISTENT AND THAT SOME OF THE STRAPS ARE TOO SHORT AND THE HOOK AND LOOP IS TOO WIDE. ALSO, THE HOOK AND LOOP IS NOT SEWN ON STRAIGHT AND THE HOOK AND LOOP EDGES ARE VERY SHARP. AS A RESULT HER DAUGHTER SUFFERED WHAT APPEAR TO BE CUTS ON HER NECK. THIS PRODUCT IS INTENDED FOR NEONATAL AND INFANT NECKS. THE DATE WHEN THE ISSUE WAS DISCOVERED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272365 TRACHEAL TUBE FIXATION DEVICE CBH J. T. POSEY CO. 8197S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK