BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELIAFIT

    MDR report key: 4603426 · Received December 24, 2014

    Report

    Report Number
    4603426
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Date of Event
    December 18, 2014
    Report Date
    December 24, 2014
    Manufacturer
    BIODERM, INC.
    Product Code
    NOA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    TWO SKIN ALTERATIONS OR SKIN TEARS NOTED ON THE VENTRAL AND DORSAL SIDES OF PENIS, DUE TO USAGE OF RELIAFIT TRIAL CATHETERS. THE PATIENT WAS COMPLAINING OF DISCOMFORT WITH THE CATHETER WHICH WAS IDENTIFIED BY PATIENT'S WIFE (WHEN PREVIOUSLY THERE HAD BEEN NO PROBLEMS WITH FUNCTION OR COMPLAINTS EVEN AFTER ASSESSMENT IN AM). THE RELIAFIT WAS REMOVED AND A NEW RELIAFIT PLACED. THE NEW CATHETER LEAKED, AND WHEN THE NURSE ATTEMPTED TO REMOVE THE SECOND RELIAFIT USING THE SUGGESTED DETACHOL SOLUTION FOR REMOVAL, SKIN CAME OFF WITH STICKY PART OF TAPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849839 RELIAFIT DEVICE, PASTE-ON FOR INCONTINANCE, NON-STERILE NOA BIODERM, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR