BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRHS D & C VAG HYST CUSTOM PACK

    MDR report key: 8623714 · Received May 17, 2019

    Report

    Report Number
    MW5086718
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 16, 2019
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OHD
    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 RAYTEC SPONGE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415280 GRHS D & C VAG HYST CUSTOM PACK GYNECOLOGICAL LAPAROSCOPIC KIT OHD AMERICAN CONTRACT SYSTEMS 983191

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention