FDA.reportPublic FDA data

MAUDE MDR 9744680

MDR report key
9744680
Report number
MW5093210
Event key
0
Event type
3
Date of event
2020-02-17
Date received
2020-02-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CPAP NASAL MASKVENTILATOR, NON-CONTINUOUS (RESPIRATOR)RESMED CORP.BZDI N
2CPAP NASAL MASKVENTILATOR, NON-CONTINUOUS (RESPIRATOR)RESMED CORP.BZDI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-210

Event Narratives#

D

Patient 1

I HAD A CPAP MASK THAT WASN'T FITTING CORRECTLY SO I TOOK IT BACK TO THE STORE ON A 30 DAY WARRANTY. THEY TRIED TO GIVE ME A TRIAL MASK THAT CLEARLY BEEN WORN WITH LOOKED TO BE UNSANITARY STUFF AROUND THE NOSE AREAS DID NOT LOOK CLEAN AT ALL. THEN I TOLD THEM I WANT A NEW ONE IN A BAG AND THEY GAVE ME ONE THAT WAS ALREADY OPENED WITH PIECES MISSING OUT OF IT. I WAS TOLD THE ORIGINAL MASK WOULD BE BILLED TO INSURANCE COMPANY, NOT THE NEW CHEAPER ONE AND THE INSURANCE SAID THEY CAN'T BILL FOR THE ONE YOU DON'T HAVE. I BELIEVE THESE PRODUCTS BEING USED AND OPEN AND NOT SAYING THEY ARE USED IS A VIOLATION OF LAW. WHEN I GOT THE MACHINE IT DIDN'T COME IN A BOX, NEW. IT WAS ALREADY OPEN IN A DUFFEL BAG NOT KNOWING IF IT WAS NEW OR NOT. FDA SAFETY REPORT ID# (B)(4).