BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PMI SOLOBAG INTRODUCTER POLYMER SPECIMEN BAG

    MDR report key: 11693080 · Received April 19, 2021

    Report

    Report Number
    MW5100855
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 16, 2021
    Manufacturer
    PROGRESSIVE MEDICAL, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PMI SOLOBAG RUPTURED WHEN PULLING BAG THROUGH SKIN. GALLBLADDER RETRIEVED WITHOUT LOSS OF CONTENTS INTO ABDOMEN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581086 PMI SOLOBAG INTRODUCTER POLYMER SPECIMEN BAG LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ PROGRESSIVE MEDICAL, INC. PPI0280 21PPI028010

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR