MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-05-17 for D3MX DEBONDING PLIER 8664015 manufactured by Ormco Corporation.
[1555101]
On (b) (6), 2009 a doctor reported to ormco corporation that a d3mx debonder scraped the enamel off a patient's tooth.
Patient Sequence No: 1, Text Type: D, B5
[8656228]
Attempts were made to contact (b) (6) via phone on may 5, 2010, and may 6, 2010 and via email on may 4, 2010 in order to obtain additional information on this incident; however no response was received. The device was not returned to ormco for evaluation. Due to lack of information, the exact cause of this incident remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2010-00062 |
| MDR Report Key | 1691748 |
| Report Source | 05 |
| Date Received | 2010-05-17 |
| Date of Report | 2009-12-17 |
| Date Mfgr Received | 2009-12-17 |
| Date Added to Maude | 2010-05-18 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| 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 | D3MX DEBONDING PLIER |
| Generic Name | DENTAL HAND INSTRUMENT |
| Product Code | JEX |
| Date Received | 2010-05-17 |
| Catalog Number | 8664015 |
| Lot Number | 11073850B |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-05-17 |