MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-06-18 for SONA PILLOW manufactured by Sleep Devices, Inc..
[18914349]
Mfr says on their web site "stops snoring & mild sleep apnea" and i bought the sona pillow based on that claim. For me, it does neither one, and it dislocated my neck. Their fda allowed claims - k040161 - are: "may stop or decrease snoring. ", may be used to treat mild obstructive sleep apnea. ", "may improve the quality of sleep. " mfr claims sona pillow absolutely "stops snoring & mild sleep apnea". This is both false and misleading. With a "no return" policy, mfr is ripping off consumers. I am currently trying to get a credit back through mastercard and am returning the sona pillow to sleep devices today. Dates of use: 1hr; 2007. Diagnosis: snoring, sleep apnea. Event abated after use stopped: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5002694 |
| MDR Report Key | 868225 |
| Date Received | 2007-06-18 |
| Date of Report | 2007-06-18 |
| Date of Event | 2007-06-11 |
| Date Added to Maude | 2007-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONA PILLOW |
| Generic Name | NONE |
| Product Code | MYB |
| Date Received | 2007-06-18 |
| Returned To Mfg | 2007-06-18 |
| ID Number | K040161 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 851658 |
| Manufacturer | SLEEP DEVICES, INC. |
| Manufacturer Address | 506 WEST CHERRY ST. KISSIMMEE FL 34741 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-06-18 |