BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GELPOINT MINI ADVANCED ACCESS PLATFORM

    MDR report key: 8683765 · Received June 7, 2019

    Report

    Report Number
    MW5087222
    Event Type
    Injury
    Date Received
    June 7, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 5, 2019
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    HEW
    UDI-DI
    10607915131781
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CLEAR PLASTIC FELL APART AND INTO PT FROM GELPOINT MINI ADVANCED ACCESS PLATFORM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474397 GELPOINT MINI ADVANCED ACCESS PLATFORM CULDOSCOPE (AND ACCESSORIES) HEW APPLIED MEDICAL RESOURCES CORP. 1348491 10607915131781

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention