MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-11 for CHEEK RETRACTOR 339-002 manufactured by Saga Dental Supply As.
[72344612]
Patient Sequence No: 1, Text Type: N, H10
[72344613]
The plastic cheek retractor from the closed reduction kit oral 339-002 broke while in use on a patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6479654 |
| MDR Report Key | 6479654 |
| Date Received | 2017-04-11 |
| Date of Report | 2017-04-05 |
| Date of Event | 2017-02-27 |
| Report Date | 2017-04-05 |
| Date Reported to FDA | 2017-04-05 |
| Date Reported to Mfgr | 2017-04-05 |
| Date Added to Maude | 2017-04-11 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHEEK RETRACTOR |
| Generic Name | ACCESSORIES, RETRACTOR, DENTAL |
| Product Code | EIF |
| Date Received | 2017-04-11 |
| Model Number | 339-002 |
| Catalog Number | 339-002 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAGA DENTAL SUPPLY AS |
| Manufacturer Address | 1712 BOLLINGWOOD DRIVE ALEXANDRIA VA 22307 US 22307 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-11 |