BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEROMACATH

    MDR report key: 8603353 · Received May 13, 2019

    Report

    Report Number
    8603353
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    February 5, 2019
    Report Date
    April 19, 2019
    Manufacturer
    GREER MEDICAL, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A MODIFIED RADICAL MASTECTOMY, THE PATIENT ENCOUNTERED SEVERAL SEROMA'S IN THE AREA OF THE MASTECTOMY WHICH WERE TREATED AND DRAINED BY HER PROVIDER IN THE CLINIC. THE DECISION WAS MADE TO PLACE A SEROMA CATHETER WITH A SUCTION BULB FOR CONTINUAL DRAINAGE. THE CATHETER ULTIMATELY SHEERED OF FROM THE HUB AND REMAINED IN THE PATIENT SKIN AND REQUIRED SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396557 SEROMACATH APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY GREER MEDICAL, INC. 071116

    Patients

    Seq Age Sex Outcome Treatment
    1 19345 DA