inforMED
MalfunctionIWY

TYPE-S HEAD, NECK & SHOULDER THERMOPLASTIC

Received Oct 5, 2017 · Event occurred May 31, 2017

Report 6915905 · MDR key 6915905

Device

Generic name

Holder, Head, Radiographic

Catalog number

MTAPSD2.4

Lot number

M931770

Product problems

  • Break

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

THERMOPLASTIC MASKS BROKE, FOUR IN A ROW, WHEN USED FOR CT SIMULATION (PREP FOR RADIATION THERAPY). FIFTH ONE DID NOT BREAK AND WAS ABLE TO BE MOLDED WITHOUT PROBLEM. SO DELAY IN COMPLETING PATIENT PROCEDURE.