BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARTER KIT, SIZE 5, 1215

    MDR report key: 86944 · Received April 21, 1997

    Report

    Report Number
    1224675-1997-00023
    Event Type
    Injury
    Date Received
    April 21, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 10, 1997
    Manufacturer
    UROMED CORP.
    Product Code
    MNG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED HAVING TROUBLE FINDING THE STRING. PT WAS SEEN BY A MEDICAL PROFESSIONAL WHO PERFORMED A PELVIC EXAM. DURING THE EXAM A DEVICE WAS FOUND IN THE PT'S VAGINA AND REMOVED BY THE MEDICAL PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARTER KIT, SIZE 5, 1215 RELIANCE MNG UROMED CORP. SIZE 5 0000000010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention