BEUDAMED
    FDA Adverse Event Summary report: N

    SELECTCELLS STANDARD ENDOMETRIAL SAMPLING DEVICE

    MDR report key: 42138 · Received October 9, 1996

    Report

    Report Number
    MW4001632
    Date Received
    October 9, 1996
    Report Date
    July 30, 1996
    Manufacturer
    SELECT MEDICAL SYSTEMS, INC.
    Product Code
    HHK
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE APPEARS TO HAVE BEEN MFG AND DISTRIBUTED WITHOUT A LOT CONTROL NUMBER AND WITHOUT AN EXPIRATION DATE FOR THE STERILIZATION OF THE DEVICE. ALSO, ALTHOUGH THE TYVEK POUCH ASSERTS "REFER TO DIRECTIONS FOR USE FOR DETAILED INSTRUCTIONS", NO DETAILED INSTRUCTIONS WERE PROVIDED WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECTCELLS STANDARD ENDOMETRIAL SAMPLING DEVICE ENDOMETRIAL SAMPLING DEVICE HHK SELECT MEDICAL SYSTEMS, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *