FDA.reportPublic FDA data

MAUDE MDR 1128062

MDR report key
1128062
Report number
MW5008032
Event key
0
Event type
3
Date of event
2008-01-01
Date received
2008-08-19
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
1COMFORT GELCOMFORT GEL MASKRESPIRONICSNMC1010640071208NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-08-1901. O

Event Narratives#

D

Patient 1

I HAVE BEEN EXPERIENCING ACUTE CONTACT DERMATITIS HIVES AND EXTREME DISCOMFORT FOR THE PAST 8 MONTHS FROM POSSIBLE BISPENOL A OR SILICONE LEACHING FROM BIPAP MASKS FOR SLEEP APNEA. THE COMPANY HAS INSTRUCTED ME TO STOP WEARING THE MASK, BUT I HAVE NO OTHER OPTIONS FOR SLEEP APNEA MASKS. I HAVE BEEN UNABLE TO FIND A LAB THAT TESTS FOR SILICONE AND BISPHENOL A CONCENTRATIONS IN BLOOD AND URINE. PLEASE, MAY SOMEONE ASSIST IN HELPING TO RESOLVE THIS PROBLEM! DOSE OR AMOUNT: 6-8 HOURS A NIGHT. FREQUENCY: DAILY USE. ROUTE: CUTANEOUS. DATES OF USE: 2006 - 2008, 6-8 HOURS PER DAY. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: NO. EVENT REAPPEARED AFTER REINTRODUCTION?: YES.