Description of Event or Problem · 0
PER FDA GUIDANCE DOCUMENT MEDICAL DEVICE REPORTING FOR MANUFACTURERS, "ANY REPORTABLE ENT INFORMATION THAT IS ERRONEOUSLY SENT TO MANUFACTURER A, FOR A DEVICE RR.2JE BY MANUFACTURER E:. SHOULD BE SENT TO THE FDA WITH A COVER LETTER EXPLAINING THAT MANUFACTURER A DOES NOT MAF THE DEVICE IN QUESTION." LNOGEN INC., HAS RECEIVED NOTIFICATION OF A POTENTIALLY REPORTABLE THREATENING EVENT REGARDING PATIENT USE OF A STATIONARY OXYGEN CONCENTRATOR MEDICAL DEVICE THAT IS NOT MANUFACTURED BY LNOGEN. THE STATIONARY OXYGEN CONCENTRATOR IS MANUFACTURED BY PHILIPS-RESPIRONICS, EVERFLO MODEL, SERIAL NUMBER (B)(6). THIS DEVICE IS NOT MANUFACTURED BY LNOGEN INC. ATTACHED IS INITIAL RECORD TAKEN OF THE INCIDENT BY LNOGEN'S CLIENT SERVICE REPRESENTATIVE. HX OF COPD AND DEPRESSION. TRANSFERRED TO PARKLAND FOR 2% TBSA FACIAL BURNS WITH CONCERN FOR AIRWAY COMPROMISE. PT USES HOME OXYGEN AND WAS ATTEMPTING TO LIGHT A GLASS MARIJUANA PIPE WHEN IT FLASH EXPLODED. SHE WAS ABLE TO REMOVE HER BURNING NASAL CANNULA FROM HER NARES AND RUN ACROSS THE STREET TO HER NEIGHBOR'S HOUSE. WHEN SHE ARRIVED TO THE OSH, SHE WAS ALERT AND ORIENTED AND ABLE TO DESCRIBE WHAT HAPPENED HOWEVER SHE WAS INTUBATED WHEN IT WAS NOTED THAT SHE HAD SIGNIFICANT BURNS TO HER NARES AND CARBONACEOUS SPUTUM. SHE WAS TRANSFERRED TO PMH FOR A HIGHER LEVEL OF CARE. PT HAD PARTIAL THICKNESS BURNS TO CHEEKS, NOSE. SEPTUM, UPPER LIP, SINGED EYEBROWS AND HAIR, SOME SOOT UNDER RIGHT FINER NAILS. SOME SUPERFICIAL BURNS AROUND EYES. UPPER LIP WITH SOME SWELLING/BURN. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).