BEUDAMED
    FDA Adverse Event Other Summary report: N

    THINPREP IMAGING SYSTEM REVIEW SCOPE

    MDR report key: 1053568 · Received May 27, 2008

    Report

    Report Number
    1222780-2008-00067
    Event Type
    Other
    Date Received
    May 27, 2008
    Date of Event
    May 9, 2008
    Report Date
    May 16, 2008
    Manufacturer
    HOLOGIC INC
    Product Code
    MNM
    PMA / PMN Number
    P020002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CYTOLOGY APPLICATION SUPPORT (CAS) SPECIALIST TO CHANGE BUTTONS ON POD AND REVIEW A DIFFERENT WAY TO HOLD THE POD. CAS ALSO SUGGESTED USING THE WRIST REST PROVIDED WITH THE POD. CUSTOMER WILL REPORT BACK IF THE SITUATION DOES NOT IMPROVE WITH SUGGESTED CHANGES.

    Description of Event or Problem · 1

    TECHNICIAN BEGAN HAVING REVERSIBLE REPETITIVE STRESS/MOTION ISSUES WITH HER HAND AFTER USING THE REVIEW SCOPE. TECHNICIAN WAS SEEN BY A PHYSICIAN AND DIAGNOSED WITH BURSITIS IN HER THUMB, TENDONITIS, AND DAMAGE TO THE LIGAMENTS IN HER FOREARM. (TECHNICIAN WAS USING THE THUMB FOR THE NEXT BUTTON AND NOT USING THE WRIST REST PROVIDED WITH THE POD.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINPREP IMAGING SYSTEM REVIEW SCOPE REVIEW SCOPE - POD MNM HOLOGIC INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other