MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-11-10 for CPAP HEADGEAR manufactured by Renaissance Medical.
[965294]
I have sleep apnea. I have been using my chin strip to close my mouth at night; so i can get o2. Last month i asked for a new chin strap from renaissance medical cpap headgear. I have made 8 phone calls to tell them the new chin straps are much smaller, must be trying to save money on the material. I have left messages and once they even called me back to say cut it off??? I called and had them record what i am saying this is a life threatening problem. The place i got it keeps telling me they will call me back. The medical office. I would be glad to get one of the old chin straps just so i can sleep but i think of all the elderly who think this is all they have and may be losing brain cells and possible heart attack because someone has decided to make them too small for people to use. Thank you, dates of use: 2008. Diagnosis or reason for use: sleep apnea.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5008910 |
| MDR Report Key | 1226124 |
| Date Received | 2008-11-10 |
| Date of Report | 2008-11-10 |
| Date of Event | 2000-10-22 |
| Date Added to Maude | 2008-11-19 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CPAP HEADGEAR |
| Product Code | NHJ |
| Date Received | 2008-11-10 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1281660 |
| Manufacturer | RENAISSANCE MEDICAL |
| Manufacturer Address | NORTH ROYALTON OH 44133 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Deathisabilit | 2008-11-10 |