MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-21 for AUSTIN RETRACTOR manufactured by Ace Surgical.
[18057685]
On (b)(6) 2013, a (b)(6) female was having a surgical procedure for dental extractions, during the procedure, while the cheek retractor was in the pt's mouth, the cheek retractor was noted to be broken with a chip missing from the end. All pieces were accounted for. The retractor was removed from surgical field along with broken piece, md aware.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030666 |
| MDR Report Key | 3193450 |
| Date Received | 2013-06-21 |
| Date of Report | 2013-06-21 |
| Date of Event | 2013-06-14 |
| Date Added to Maude | 2013-06-28 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUSTIN RETRACTOR |
| Generic Name | AUSTIN RETRACTOR |
| Product Code | EIG |
| Date Received | 2013-06-21 |
| Lot Number | 417-4002 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACE SURGICAL |
| Manufacturer Address | 1034 PEARL ST BROCTON MA 02303 US 02303 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-21 |