Proteus 235 Proteus ONERecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05404013821303), received between May 25, 2022 and Jun 17, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Compatibility Problem; Adverse Event Without Identified Device or Use Problem

  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).

  Patient problems: Radiodermatitis

  MAUDE report 14731606 ↗
• InjuryMay 25, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Radiodermatitis

  MAUDE report 14497661 ↗