BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOSTAT

    MDR report key: 5758837 · Received June 29, 2016

    Report

    Report Number
    1423395-2016-00043
    Event Type
    Injury
    Date Received
    June 29, 2016
    Date of Event
    May 31, 2016
    Report Date
    June 29, 2016
    Manufacturer
    TECHNICALITY, INC.
    Product Code
    HTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A PROCEDURE, IT WAS REPORTED THAT A PIECE OF THE HEMOSTAT BROKE OFF AND ALLEGEDLY A PIECE FELL INTO THE BODY CAVITY. WE HAVE NOT BEEN PROVIDED ANY ADDITIONAL INFORMATION REGARDING THIS INCIDENT. A SAMPLE WAS RECEIVED AND EVALUATED. VISUAL INSPECTION REVEALED THAT ONE OF THE TIPS OF THE HEMOSTAT BROKE OFF. DETAILS REGARDING HOW THE HEMOSTAT WAS BEING USED WERE NOT PROVIDED. THE DEVICE IS A COMPONENT IN A CUSTOM PROCEDURAL PACK AND IS MANUFACTURED BY (B)(4). THE SAMPLE HAS BEEN SENT TO (B)(4) FOR THEIR EVALUATION. AS THE MANUFACTURER OF THE DEVICE, THEY WILL MAKE THE DETERMINATION IF ANY CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE HEMOSTAT BROKE DURING A PROCEDURE AND ALLEGEDLY A PIECE FELL INTO THE BODY CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412654 HEMOSTAT HTD TECHNICALITY, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other