REDIFOAM TWO-PART FOAMING AGENT

Description of Event or Problem

THE USER NOTIFIED THE FDA VIA VOLUNTARY REPORTING FORMS, IDENTIFIED BELOW, STATING "AFTER CONSTRUCTION OF THE PATIENT'S BODY MOLD AND SIMULATION, THERAPISTS NOTICED REDIFOAM MIX WAS NOT HARDENING LIKE IT USUALLY DOES (IT DIMPLED TO THE TOUCH). AFTER ROUGHLY 24 HOURS, THERAPISTS NOTICED PATIENT'S BODY MOLD BEGAN TO SHRINK AND LOSE ITS FORM OR SHAPE WHICH COULD CAUSE MISALIGNMENT OF RADIATION TREATMENT. A NEW SIMULATION AND BODY MOLD HAD TO BE CREATED WHICH COULD HAVE CAUSED A DELAY IN THE PATIENT'S CANCER TREATMENTS." DEATH OR SERIOUS INJURY DID NOT OCCUR AND WOULD BE LIKELY TO OCCUR. FACILITY MDR NUMBERS: (B)(4) - EVENT DATE: (B)(6) 2022. (B)(4) - EVENT DATE: (B)(6) 2022. (B)(4) - EVENT DATE: (B)(6) 2022. (B)(4) - EVENT DATE: (B)(6) 2022. (B)(4) - EVENT DATE: (B)(6) 2022. (B)(4) - EVENT DATE: (B)(6) 2022.

Additional Manufacturer Narrative

POOR EXPANSION OF AN INCORRECT RATIO OF PART A & PART B IS HIGHLY DETECTABLE BY THE USER DURING THE FORMING PROCESS AS THE MATERIAL IS SOFT AND WILL HAVE FURTHER SHRUNK PRIOR TO TREATMENT, THUS EITHER CAUSING DIFFICULTY OF FITTING PATIENT OR THE PATIENT NOT FITTING BACK INTO THE SYSTEM. PATIENT MISTREATMENT IS UNLIKELY DUE TO THE HIGH DETECTABILITY OF THE ISSUE. HOWEVER, FOR THE REDIFOAM WITH POOR EXPANSION TO CAUSE MISTREATMENT THE USER WOULD HAVE TO NOT DETECT THE SOFTNESS, DUE TO UNDER-REACTION, USE NO OTHER POSITIONING DEVICES, NOT PERFORM PATIENT POSITION VERIFICATION CHECKS, AND ALSO BE TREATING WITH HYPO-FRACTIONATION. THE USER IS HIGHLY LIKELY TO DETECT THE REDIFOAM IS SOFT THROUGH TOUCH OR DIDN'T PROPERLY EXPAND PRIOR TO TREATMENT AS THE PATIENT WOULD NOT FIT INTO THE PREVIOUS FORMED UNIT, IMAGING OF THE PATIENT WOULD SHOW MISALIGNMENT AND THE LIKELIHOOD OF AN ADVERSE EVENT OCCURRING WOULD BE IMPROBABLE DUE TO THE COMBINATION OF EVENTS REQUIRED. THEREFORE, DUE TO THE COMBINATION OF EVENTS REQUIRED, HIGH DETECTION, AND LOW OCCURRENCE THE RISK IS CONSIDERED LOW AND NO REPORTING OR FIELD ACTION IS NECESSARY. CIVCO RT IS FILING A CORRESPONDING MDR IN RESPONSE TO FILING BY THE USER SITE.