BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE INCOURAGE SYSTEM

    MDR report key: 7057949 · Received November 24, 2017

    Report

    Report Number
    3004961434-2017-00001
    Event Type
    Injury
    Date Received
    November 24, 2017
    Date of Event
    July 1, 2017
    Report Date
    October 26, 2017
    Manufacturer
    RESPIRATORY TECHNOLOGIES, INC.
    Product Code
    BYI
    UDI-DI
    00841561102778
    PMA / PMN Number
    K051383
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. WITHOUT THE RETURN OF THE PRODUCT, NO CONCLUSIONS CAN BE MADE REGARDING THE EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING PATIENT INFORMATION, PATIENT OUTCOME, AND WHETHER PATIENT RECEIVED ADDITIONAL INTERVENTION. AT THIS TIME NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE TO RESPIRATORY TECHNOLOGIES. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RESPIRATORY TECHNOLOGIES RECEIVED INFORMATION DURING ROUTINE FOLLOW-UP THAT A PATIENT EXPERIENCED A RUPTURE OF ONE OF THE PATIENT'S SALINE BREAST IMPLANTS FOLLOWING THE USE OF THE INCOURAGE AIRWAY CLEARANCE THERAPY SYSTEM. THERE HAVE BEEN NO ADVERSE EVENTS REPORTED BY THE PATIENT IN THE MONTHS SINCE THE EVENT OCCURRED. THE PATIENT HAD CONSULTED WITH HER PHYSICIAN AND THE PHYSICIAN STATED THERE ARE NO RISKS DUE TO THE RUPTURE. THE INCOURAGE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS, BUT PRODUCT RETURN IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836969 THE INCOURAGE SYSTEM AIRWAY CLEARANCE VEST THERAPY BYI RESPIRATORY TECHNOLOGIES, INC. ICS-1M-US 00841561102778

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other