inforMED
InjuryLRT

INDICATOR, STERILIZATION

Received Sep 10, 2025 · Event occurred Sep 2, 2025

Report MW5175818 · MDR key 23015565

Device

Generic name

Indicator, Sterilization

Manufacturer

Unknown

Product problems

  • Radiation Overexposure

Patient

66 YR · Unknown

  • Unintended Radiation Exposure
  • Unintended Radiation Exposure

Narrative

Description of Event or Problem

PATIENT ARRIVED AT CLINIC ON (B)(6) 2025 AND WAS DIRECTLY ADMITTED TO THE HOSPITAL FOR FAILURE TO THRIVE. PATIENT REMAINS ADMITTED AS OF (B)(6) 2025. PER TREATING INVESTIGATOR, THIS EVENT IS UNLIKELY TO BE RELATED TO STUDY RADIATION. PATIENT RECEIVED A TOTAL DOSE OF 5000 CGY (B)(6) 2025, (B)(6) 2025.