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 |