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MEDTEC DISPOSABLE TYPE-S THERMOPLASTIC MASK

Received Jul 1, 2005 · Event occurred Jun 24, 2005

Report 1932738-2005-00010 · MDR key 619622

Device

Generic name

Radiographic Head Holder

Manufacturer

Medtec

Model number

MT-APSID-27-32

Catalog number

AT-APSID-27-32

Lot number

*

Product problems

  • Sticking
  • Stretched

Patient

*

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

CUSTOMER STATED THEY HAD PT WHERE THEY COULD NOT REMOVE DISPOSABLE TYPE-S THERMOPLASTIC. PT WAS EVENT IN DISTRESS. THE DEPARTMENT RECEIVED ASSISTANCE FROM ANOTHER DEPARTMENT FOR REMOVAL OF THE THERMOPLASTIC. THE PT HAD A TRACHEOTOMY TUBE WHICH WAS REMOVED FROM THE PT WHEN THE DISPOSABLE THERMOPLASTIC WAS FINALLY REMOVED FROM THE TYPE-S. THE TRACH WAS STUCK TO THE THERMOPLASTIC. THERMOPLASTIC WAS NOT CUT AWAY FROM TRACH. IT WAS STRETCHED OVER TRACH. PT IS FINE. PT WILL BE VISITING FACILITY NEXT WEEK FOR TREATMENT.

Remedial action

  • Other