BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEROMACATH

    MDR report key: 7681091 · Received July 12, 2018

    Report

    Report Number
    7681091
    Event Type
    Malfunction
    Date Received
    July 12, 2018
    Date of Event
    June 25, 2018
    Report Date
    July 5, 2018
    Manufacturer
    GREER MEDICAL, INC.
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING SEROMA DRAIN CATHETER THE 10 MM TIP REMAINED WITHIN THE SUBCUTANEOUS TISSUE. (TIP OF CATHETER SHEARED OFF AT LEVEL OF DISTAL PERFORATIONS.) PLASTIC SURGERY STAFF WAS CONTACTED AFTER THE PATIENT WAS INFORMED. RADIOLOGY PHYSICIAN THEN SPOKE WITH PLASTIC SURGEON BY PHONE TO REVIEW THE INCIDENT. HE REQUESTED THAT THE STAFF IN PLASTICS PRESCRIBE HER A COURSE OF ANTIBIOTICS AS SHE WAS NOT DUE FOR HER SURGERY FOR SEVERAL WEEKS AND THE CATHETER FRAGMENT WAS NOT VISIBLE AT THE SKIN. THE SITE OF THE LOCATION OF THE CATHETER FRAGMENT WAS MARKED ON THE SKIN AND THE PLASTICS STAFF PHOTOGRAPHED THE PATIENT'S AFFECTED (LEFT) RECONSTRUCTED BREAST TO AID IN LOCALIZATION AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524388 SEROMACATH APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY GREER MEDICAL, INC. 1035 POUCH 061617

    Patients

    Seq Age Sex Outcome Treatment
    1 22995 DA Other