MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-21 for CPAP NASAL MASK manufactured by Resmed Corp..
[180902195]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093210 |
| MDR Report Key | 9744680 |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-17 |
| Date Added to Maude | 2020-02-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPAP NASAL MASK |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-02-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP. |
| Brand Name | CPAP NASAL MASK |
| Generic Name | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) |
| Product Code | BZD |
| Date Received | 2020-02-21 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |