BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSUS HEALTHCARE SRT-100

    MDR report key: 8927119 · Received August 23, 2019

    Report

    Report Number
    3008513398-2019-00003
    Event Type
    Injury
    Date Received
    August 23, 2019
    Date of Event
    July 25, 2019
    Report Date
    August 23, 2019
    Manufacturer
    SENSUS HEALTHCARE, INC
    Product Code
    JAD
    PMA / PMN Number
    K123985
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SRT-100 SYSTEM USED TO DELIVER THERAPY OPERATED WITHIN ITS NORMAL DESIGN PARAMETERS. NO ISSUES ASSOCIATED WITH THIS SYSTEM HAVE BEEN NOTED DURING THE INITIAL REVIEW MANUFACTURING TESTING, INSPECTION, INSTALLATION, AND SERVICING RECORDS. THE DEVICE HAS BEEN MAINTAINED AND AN INSPECTION BY SERVICE PERSONNEL SHOWED THE DEVICE OPERATING WITHIN NORMAL PARAMETERS WITH NO ANOMALIES.

    Description of Event or Problem · 1

    THE DOCTOR CONTACTED SENSUS ON (B)(6) 2019 BECAUSE SHE HAD RECENTLY BECOME AWARE OF A PATIENT WHO EXPERIENCED A BREAKDOWN IN THE TREATMENT AREA. THE DOCTOR STATED THAT UPON FIRST EXHIBITING THESE SIGNS, THE PATIENT WAS STILL UNDERGOING TREATMENT. THE PATIENT WAS GIVEN A BREAK AND THE DOCTOR THAT SHE HAD SOUGHT MEDICAL ATTENTION FOR THE WOUND. THE PATIENT DID NOT RETURN TO COMPLETE THE REMAINDER OF THEIR TREATMENTS. SENSUS CLINICAL SUPPORT TEAM WAS NOTIFIED AND CONTACTED THE DOCTOR FOR MORE DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720221 SENSUS HEALTHCARE SRT-100 SYSTEM, THERAPEUTIC, X-RAY JAD SENSUS HEALTHCARE, INC SRT-100

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other