BEUDAMED
    FDA Adverse Event Other Summary report: N

    MORCELLEX

    MDR report key: 1887327 · Received October 27, 2010

    Report

    Report Number
    MW5017918
    Event Type
    Other
    Date Received
    October 27, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 27, 2010
    Manufacturer
    ETHICON GYNECARE
    Product Code
    HET
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FAILURE DURING CASE: WOULD NOT FUNCTION PROCEDURE: SUPRACERVICAL HYST. PHYSICIAN: (B)(6). CLINICIAN: (B)(6). AWAITING RETURN CALL TO CONFIRM REPLACEMENT AND DISPOSITION INSTRUCTIONS. IS IT FEASIBLE TO HAVE ALL MFR'S MARK RETURN ADDRESS AND CONTACT NUMBERS FOR ALL PRODUCTS ON EXTERIOR PACKAGING TO FACILITATE QUALITY CONCERNS WITH CONSUMERS? (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MORCELLEX MORCELLEX HET ETHICON GYNECARE MT214282

    Patients

    Seq Age Sex Outcome Treatment
    1