MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-27 for MOUTHGUARD 1191025 manufactured by Bioseal.
[115220407]
Patient underwent microdirect laryngoscopy with left microflap excision of left vocal cord lesion. When the mouthguard was removed at the end of the procedure, it was found to have a hole in it where the front teeth had met. The md is concerned that there is the potential for pieces to get in the airway.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7725929 |
| MDR Report Key | 7725929 |
| Date Received | 2018-07-27 |
| Date of Report | 2018-07-19 |
| Date of Event | 2018-07-06 |
| Report Date | 2018-07-19 |
| Date Reported to FDA | 2018-07-19 |
| Date Reported to Mfgr | 2018-07-27 |
| Date Added to Maude | 2018-07-27 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | RISK MANAGER |
| 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 | 3 |
| Brand Name | MOUTHGUARD |
| Generic Name | PROTECTOR, DENTAL |
| Product Code | BRW |
| Date Received | 2018-07-27 |
| Catalog Number | 1191025 |
| Lot Number | 400447 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOSEAL |
| Manufacturer Address | 167 WEST ORANGETHORPE AVE. PLACENTIA CA 92870 US 92870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-27 |