MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-10-11 for DAMON COPPER NITI WIRE 205-1902 manufactured by Ormco Corporation.
[11374056]
Multiple attempts were made to contact the complainant in order to obtain further patient heath information; however, the complainant has remained unresponsive. An update will be provided if any new information becomes available. The product was not returned; therefore, a physical evaluation was performed on a retained sample, yielding results within specifications.
Patient Sequence No: 1, Text Type: N, H10
[20266093]
A doctor alleged that the damon cuniti arch form had broken in a patient's mouth and the patient had swallowed the broken part.
Patient Sequence No: 1, Text Type: D, B5
[20492773]
The patient sought medical attention at a hospital for treatment. The patient was administered a general anesthetic and the broken part was removed from her throat. To date, the patient has fully recovered and is doing fine. The product was not returned. An evaluation of retained product is anticipated, but has not yet begun.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2013-00106 |
| MDR Report Key | 3407071 |
| Report Source | 05,07 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-10-03 |
| Date Mfgr Received | 2013-10-03 |
| Date Added to Maude | 2013-10-15 |
| 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 | MRS. KERRI CASINO |
| Manufacturer Street | 1717 W COLLINS AVE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167634 |
| 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 | DAMON COPPER NITI WIRE |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | DZC |
| Date Received | 2013-10-11 |
| Catalog Number | 205-1902 |
| Lot Number | 12L190L |
| Operator | OTHER |
| Device Availability | N |
| 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 AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2013-10-11 |