FDA.reportPublic FDA data

MAUDE MDR 1938534

MDR report key
1938534
Report number
MW5018690
Event key
0
Event type
3
Date of event
2008-01-01
Date received
2010-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RESPIRONICS, INC.COMFORTGEL MASK W/HGR, DOM SIZE SMALLRESPIRONICS, INC.BYPHCPCS A7034REF 1009041101102 Y
2RESPIRONICS, INC.COMFORTGEL MASK W/HGR, DOM SIZE SMALLRESPIRONICS INC.BYPA7035 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-2101. O; 2. R

Event Narratives#

D

Patient 1

INCREASING REACTION TO THE TOXIC FUMES THAT CHINESE MADE COMFORTGEL NASAL MASK BY RESPIRONICS INC DISCHARGES TO THE POINT THAT I SUFFOCATE FROM COMPLETE AIRWAY BLOCKAGE DURING SLEEP. THIS MASK WAS PROVIDED TO ME BY (B)(6). I HAVE COMPLAINED NUMEROUS TIMES TO (B)(6) SLEEP LAB TECHS, DR. (B)(6), AT NO AVAIL. DOSE OR AMOUNT: SLEEP APNEA TREATMENT, FREQUENCY: EVERY DAY. DATES OF USE: COMFORTGEL NASAL MASK FOR CPAP SINCE 2008. DIAGNOSIS OR REASON FOR USE: OBSTRUCTIVE SLEEP APNEA.