MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-08 for DENTAL ORAL APPLIANCE FOR SLEEP APNEA manufactured by Unknown.
[141505476]
Reporter stated that he had sleep apnea studies and qualified to use the mandible bar oral dental appliance which is a two piece appliance, attached by a bar holding the device together in his mouth. Shortly after use of this device, he woke up in the middle of the night with mouth wide open, device separated and clip holding the device together was not found. He is certain that he swallowed this component. He visited an oral surgeon who sent out the device for repairs. On (b)(6) 2019, he wore the repaired device and a similar incidence happened. He could not find the clip and believes he swallowed it again. Reporter is very concerned that these clips he swallowed could destroy or perforate his intestines. He insists the company changes the way the device is assembled/manufactured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085701 |
| MDR Report Key | 8497144 |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-08 |
| Date of Event | 2019-01-01 |
| Date Added to Maude | 2019-04-09 |
| 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 | 0 |
| Brand Name | DENTAL ORAL APPLIANCE FOR SLEEP APNEA |
| Generic Name | DEVICE ANTI SNORING |
| Product Code | LRK |
| Date Received | 2019-04-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-08 |