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

Model Number	PROTEUS 235
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Radiodermatitis (2255)
Type of Reportable Event	Serious Injury
Event or Problem Description
On april 28, 2022, iba was made aware that a patient developed a severe skin reaction following a proton therapy treatment that was started on (b)(6) 2022.Excessive skin reactions can be explained by different causes.Iba's investigation is ongoing.A supplemental report will be submitted once the investigation has been completed.
Additional Manufacturer Narrative
Section h3: evaluation summary is provided in section b5 (describe event or problem).
Event or Problem Description
Event description: iba reference: (b)(4).On april 28, 2022, iba was made aware that a patient developed a delayed unanticipated skin reaction towards the end of a course of proton therapy treatment that was started on (b)(6) 2022.The patient had received 36 of 39 fractions.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.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.

• 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: 14497661
• Report Number: 3000256071-2022-00002
• Device Sequence Number: 5106571
• Product Code: LHN
• UDI-Device Identifier: 05404013821303
• UDI-Public: (01)05404013821303(11)190626
• Combination Product (Y/N): N
• 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): 04/28/2022

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: PROTEUS 235
• Device Catalogue Number: PROTEUS 235
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/25/2022
• 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