MAUDE MDR 5305985

MDR report key
5305985
Report number
MW5058551
Event key
0
Event type
3
Date of event
2015-10-30
Date received
2015-12-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Report source
P
Manufacturer link flag
N

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SINUPULSE ELITENASAL IRRIGATORKARELITE* *
2RESMED CPAPCPAP MACHINERESMEDBZD* *

Patients

SequenceReceivedTreatmentOutcome
12015-12-1401. H; 2. L; 3. O; 4. R

Event Narratives

D

Patient 1

I USE A SINUPULSE ELITE NASAL WASH SYSTEM AND A RESMED CPAP WITH AN INTEGRATED HUMIDIFIER. I USE DISTILLED WATER IN BOTH DEVICES. I HAVE BEEN USING THE SINUPULSE FOR ABOUT 2 YEARS AND THE CPAP FOR ABOUT 6 MONTHS. I SUDDENLY DEVELOPED A SINUS INFECTION WHICH COMPLETELY CLOSED MY EYE. I WAS RUSHED TO THE EMERGENCY ROOM AND ADMITTED TO THE HOSPITAL. I HAD TWO EMERGENCY SURGERIES ON MY EYE AND SINUSES (TWO SURGICAL TEAMS AT THE SAME TIME). THE DRAINAGE WAS CULTURED AND DETERMINED TO BE PSEUDOMONAS. I HAD NO RECENT PROCEDURES OR HOSPITALIZATIONS. THE DIAGNOSIS WAS ORBITAL CELLULITIS/ABCESS AND SINUSITIS CAUSED BY PSEUDOMONAS. NEITHER THE SINUPULSE OR RESMED CPAP WARNED OF THIS POSSIBILITY OR DISCUSSED HOW TO DISINFECT THEIR MACHINES. I USED DISTILLED WATER IN BOTH MACHINES.

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