MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-12-09 for ETM FLUSH CUT DISTAL-END CUTTER WITH SAFETY HOLD 800-0516 manufactured by Ormco Corporation.
[62113153]
It was alleged that a patient was sent to an oral surgeon and surgical intervention may have been required; however no further specific information has been received at this time. An update will be provided upon receipt of new information.
Patient Sequence No: 1, Text Type: N, H10
[62113154]
It was alleged that a patient was sent to an oral surgeon to remove distal end that did not hold and lodged into patients cheek.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2016-00007 |
| MDR Report Key | 6159692 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-12-09 |
| Date of Report | 2016-11-15 |
| Date Mfgr Received | 2016-11-15 |
| Date Added to Maude | 2016-12-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ETM FLUSH CUT DISTAL-END CUTTER WITH SAFETY HOLD |
| Generic Name | ETM DISTAL CUTTER |
| Product Code | EKD |
| Date Received | 2016-12-09 |
| Catalog Number | 800-0516 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-09 |