MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-18 for TEETH GUARD * 50-2275 manufactured by Pilling.
[383572]
In 2004 pt for micro-direct laryngoscopy/bilateral excision of vocal cord lesions. Rubber tooth protector placed on upper teeth. At conclusion of procedure, roughened area on back of right central incision noted. Tooth guard inspected and noted that pt's tooth had sliced through rubber of tooth guard. Pt to follow up with dentist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 567412 |
| MDR Report Key | 567412 |
| Date Received | 2005-01-18 |
| Date of Report | 2004-11-18 |
| Date of Event | 2004-10-18 |
| Date Facility Aware | 2004-10-18 |
| Report Date | 2004-11-18 |
| Date Added to Maude | 2005-01-26 |
| 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 |
| 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 | TEETH GUARD |
| Generic Name | TOOTH PROTECTOR |
| Product Code | BRW |
| Date Received | 2005-01-18 |
| Model Number | * |
| Catalog Number | 50-2275 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 557224 |
| Manufacturer | PILLING |
| Manufacturer Address | 420 DELAWARE DRIVE FORT WASHINGTON PA 19034 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-18 |