MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-07 for DENTAL APPLIANCE USED FOR SLEEP APNEA. manufactured by Unk.
[54295676]
Reporter called on behalf of his mother, (b)(6), regarding her dental appliance she uses to treat her sleep apnea. Reporter stated that a year ago, his mother was experiencing pain in her teeth and mouth believed to be caused by her dental appliance. When the techs removed the dental appliance, she would feel sick. Reporter is unsure if his mother is still experiencing pain, but would like her to receive a replacement to assure it's working properly for her. Reporter believes she is still wearing the device today. Address for (b)(6). Information for treating dentist: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5064594 |
| MDR Report Key | 5935402 |
| Date Received | 2016-09-07 |
| Date of Report | 2016-09-07 |
| Date of Event | 2015-08-01 |
| Date Added to Maude | 2016-09-08 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 0 |
| Brand Name | DENTAL APPLIANCE USED FOR SLEEP APNEA. |
| Generic Name | DENTAL APPLIANCE USED FOR SLEEP APNEA. |
| Product Code | PLC |
| Date Received | 2016-09-07 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2016-09-07 |