BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE CHANNEL DRAIN (15FR SILICONE)

    MDR report key: 8540896 · Received April 22, 2019

    Report

    Report Number
    MW5086057
    Event Type
    Injury
    Date Received
    April 22, 2019
    Report Date
    April 18, 2019
    Manufacturer
    CARDINAL HEALTH 200 LLC
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD 2 JP DRAINS POST SURGERY. BOTH DRAINS WERE REMOVED WITHOUT INCIDENT WHILE PT WAS INPATIENT. PT RETURNED TO THE ED A FEW DAYS POST D/C WITH ABDOMINAL PAIN AND VOMITING. IT WAS FOUND THAT THERE WAS A DRAIN IN THE ABDOMEN THAT WAS NOT EXPECTED TO BE THERE AS THEY WERE REMOVED BEFORE SHE WAS DISCHARGED. SURGICAL REMOVAL OF THE REMAINING DRAIN WAS NEEDED. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331636 BLAKE CHANNEL DRAIN (15FR SILICONE) INTRODUCTION/DRAINAGE CATHETER AND ACCESSORIES GBX CARDINAL HEALTH 200 LLC JP2188

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| O