BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE FALOPE RING BAND APPLICATOR KIT

    MDR report key: 2599639 · Received May 31, 2012

    Report

    Report Number
    2183680-2012-00030
    Event Type
    Injury
    Date Received
    May 31, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 4, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    KNH
    PMA / PMN Number
    P870076
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE WHILE USING THE INSTRUMENT, TWO DID NOT FIRE AND ONE CAUSED TEARING TO THE FALOPE TUBE. THE PROCEDURE WAS COMPLETED WITH ONE FROM ANOTHER PACK. THERE WAS NO EXTENDED STAY OR OTHER HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE FALOPE RING BAND APPLICATOR KIT FALOPE RING BAND APPLICATOR KIT KNH GYRUS MEDICAL, INC. 006889-901 408084AE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other