MAUDE Adverse Event Report: IBA (ION BEAM APPLICATIONS) PROTEUSONE; PROTON THERAPY SYSTEM

Model Number	PROTEUS235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Radiodermatitis (2255)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
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).
Event or Problem Description
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.
Additional Manufacturer Narrative
Section h3: evaluation summary is provided in section b5 (describe event or problem).

• Brand Name: PROTEUSONE
• Common Device Name: PROTON THERAPY SYSTEM
• Manufacturer (Section D): IBA (ION BEAM APPLICATIONS); chemin du cyclotron, 3; louvain-la-neuve, 1348 ; BE 1348
• Manufacturer Contact: sylviane berger ; chemin du cyclotron, 3; louvain-la-neuve, 1348 ; BE 1348
• MDR Report Key: 14731606
• Report Number: 3000256071-2022-00003
• Device Sequence Number: 5649145
• Product Code: LHN
• UDI-Device Identifier: 05404013821303
• UDI-Public: (01)05404013821303(11)190626
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K163500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PROTEUS235
• Device Catalogue Number: PROTEUS235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/19/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown