BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDLINE SILICONE BULB EVACUATOR - JP DRAIN

    MDR report key: 8857053 · Received July 31, 2019

    Report

    Report Number
    MW5088695
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    June 21, 2019
    Report Date
    July 19, 2019
    Manufacturer
    CONOD MEDICAL CO., LIMITED
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    JP DRAIN PLACED DURING ACUTE SURGICAL INTERVENTION. DRAIN DID NOT EFFECTIVELY WORK AS THERE WAS RESIDUAL BLEEDING IN THE DRAINAGE TUBE BUT NOT IN THE COLLECTION CHAMBER. BUILD UP OF RECURRENT BLEEDING REQUIRED ANOTHER SURGICAL INTERVENTION THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638802 MEDLINE SILICONE BULB EVACUATOR - JP DRAIN APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED GCY CONOD MEDICAL CO., LIMITED DYNJWE1305

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention