MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-08-15 for STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE 03-XXX-XX manufactured by Gac International.
[23219743]
No additional information is available at this time. However, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such. This event, therefore, is reportable per 21 cfr part 803. The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
[23219744]
In this event an attorney reported that an adult orthodontic patient claims to have swallowed an archwire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2418500-2015-00003 |
| MDR Report Key | 5008532 |
| Report Source | OTHER |
| Date Received | 2015-08-15 |
| Date of Report | 2015-07-17 |
| Date Mfgr Received | 2015-07-17 |
| Date Added to Maude | 2015-08-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | SUSQUEHANNA COMMERCE CTR W. 221 W. PHILADELPHIA ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STAINLESS STEEL GOLD ACCU-FORM ARCHWIRE |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | ECN |
| Date Received | 2015-08-15 |
| Catalog Number | 03-XXX-XX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAC INTERNATIONAL |
| Manufacturer Address | ISLANDIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-15 |