MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-04 for SONA PILLOW * manufactured by Sleep Devices, Inc..
[615562]
Purchased sona pillow -fda #k040161-and used according to instructions. Resulted in disabling neck pain. Wanted to return the "medical device" and was told by company -sleep devices inc. - it was not returnable due to fda regulations. ** i researched the fda approval of this "device" and found it was approved "under 872. 557, intraoral devices for snoring and obstructive sleep apnea. " please note, this is not an intraoral device - it is a pillow that you place your head on during sleep. **quote from www. Sonapillow. Com "returns/policies federal laws on returning bedding products are similar to the laws governing the return of underwear. Furthermore, the sona pillow is a personal medical device. Used medical equipment cannot be returned, unless there is a mfg defect in the product. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042805 |
| MDR Report Key | 850625 |
| Date Received | 2007-05-04 |
| Date of Report | 2007-05-04 |
| Date of Event | 2007-05-03 |
| Date Added to Maude | 2007-05-16 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONA PILLOW |
| Generic Name | SONA PILLOW |
| Product Code | MYB |
| Date Received | 2007-05-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | FDA # K040161 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 837524 |
| Manufacturer | SLEEP DEVICES, INC. |
| Manufacturer Address | * KISSIMMEE FL 34741 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-05-04 |