BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRHS CUSTOM C-SECTION PACK

    MDR report key: 8624217 · Received May 17, 2019

    Report

    Report Number
    MW5086751
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 7, 2019
    Report Date
    May 16, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OHM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HAIR FOUND IN CUSTOM C-SECTION PACK WHILE SETTING UP CASE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415498 GRHS CUSTOM C-SECTION PACK CESAREAN SECTION TRAY OHM AMERICAN CONTRACT SYSTEMS 990191

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR