BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIER

    MDR report key: 342330 · Received July 13, 2001

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    Report

    Report Number
    2521453-2001-00001
    Event Type
    Malfunction
    Date Received
    July 13, 2001
    Date of Event
    June 19, 2001
    Report Date
    July 13, 2001
    Manufacturer
    PREMIER MEDICAL (MFG)
    Product Code
    HDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TIP OF A TEFLON DILATOR BROKE OFF IN A PT'S UTERUS AND WAS REMOVED.

    Description of Event or Problem · 1

    COMPANY WAS ADVISED THAT THE TIP OF A TEFLON INSTRUMETN BROKE OFF IN A PATIENT UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31949 PREMIER UTERINE DILATOR HDQ PREMIER MEDICAL (MFG) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other