BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEUSONE

    MDR report key: 14731606 · Received June 17, 2022

    Report

    Report Number
    3000256071-2022-00003
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 19, 2022
    Manufacturer
    IBA (ION BEAM APPLICATIONS)
    Product Code
    LHN
    UDI-DI
    05404013821303
    PMA / PMN Number
    K163500
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H3: EVALUATION SUMMARY IS PROVIDED IN SECTION B5 (DESCRIBE EVENT OR PROBLEM).

    Description of Event or Problem · 0

    EVENT DESCRIPTION: ON MAY 19, 2022, IBA WAS MADE AWARE THAT A PATIENT DEVELOPED A DELAYED UNANTICIPATED SKIN REACTION FOLLOWING A PROTON THERAPY TREATMENT COMPLETED MID-MARCH 2022. THIS REACTION WAS DISCOVERED DURING A CLINICAL FOLLOW-UP ON MAY 18, 2022. EXCESSIVE SKIN REACTION CAN BE EXPLAINED BY DIFFERENT CAUSES. IBA'S INVESTIGATION IS ONGOING. THE PRELIMINARY RESULTS SHOW THAT THE SYSTEM BEHAVED AS EXPECTED, WITHOUT ANY MALFUNCTION. FURTHERMORE, THE IMPACTED PATIENT RECEIVED A VACCINE AGAINST COVID-19 AND RADIATION RECALL DERMATITIS CASES HAVE BEEN REPORTED AS MORE FREQUENT WITH THE ADMINISTRATION OF COVID-19 VACCINE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. IBA REFERENCE: (B)(4).

    Description of Event or Problem · 0

    EVENT DESCRIPTION: IBA REFERENCE: (B)(4) ON MAY 19, 2022, IBA WAS MADE AWARE THAT A PATIENT DEVELOPED A DELAYED UNANTICIPATED SKIN REACTION FOLLOWING A PROTON THERAPY TREATMENT COMPLETED MID-MARCH 2022. THIS REACTION WAS DISCOVERED DURING A CLINICAL FOLLOW-UP ON (B)(6) 2022. SUCH SKIN REACTION COULD BE CAUSED BY EITHER: A) AN OVER-IRRADIATION WITHIN THE TREATMENT FIELD, B) PATIENT-SPECIFIC RADIATION SENSITIVITY, OR C) A COMBINATION OF THE PROTON IRRADIATION WITH ANOTHER TREATMENT SUCH AS DRUG, VACCINE, CREAM (RADIATION RECALL DERMATITIS). THE IMPACTED PATIENT RECEIVED A VACCINE AGAINST COVID-19 AND RADIATION RECALL DERMATITIS CASES HAVE BEEN REPORTED AS MORE FREQUENT WITH THE ADMINISTRATION OF COVID-19 VACCINE. THE PRELIMINARY RESULTS SHOWED THAT THE SYSTEM BEHAVED AS EXPECTED, WITHOUT ANY MALFUNCTION. EVALUATION SUMMARY: AFTER ANALYSIS OF THE CLINICAL, SYSTEM, AND IRRADIATIONS LOGS, IBA DID NOT IDENTIFY ANY TECHNICAL ISSUE WITH THE EQUIPMENT THAT WOULD CAUSE AN OVERDOSAGE TO THE SKIN OF THE PATIENT UNDER INVESTIGATION. IBA BELIEVES IT HAS INVESTIGATED ALL POTENTIAL TECHNICAL FAILURES AND THAT NO FURTHER TECHNICAL INVESTIGATION WILL BRING NEW ELEMENTS TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203139 PROTEUSONE PROTON THERAPY SYSTEM LHN IBA (ION BEAM APPLICATIONS) PROTEUS235 05404013821303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other