MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-27 for WECK 764FG * manufactured by Teleflex Medical.
[15500860]
The mouth gag was placed in patient's mouth for surgical procedure. The instrument snapped apart while still in patient's mouth. Suddenly, the mouth closed. Dr. Examined teeth and mouth. There was no apparent injury noticed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1675634 |
| MDR Report Key | 1675634 |
| Date Received | 2010-04-27 |
| Date of Report | 2010-04-27 |
| Date of Event | 2010-04-12 |
| Report Date | 2010-04-27 |
| Date Reported to FDA | 2010-04-27 |
| Date Added to Maude | 2010-05-06 |
| 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 | 0 |
| 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 | WECK |
| Generic Name | GAG, MOUTH PIECE |
| Product Code | KBN |
| Date Received | 2010-04-27 |
| Model Number | 764FG |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PO BOX 12600 DURHAM NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-27 |