MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for CUNITI WIRE manufactured by Sds De Mexico S. De R.l. De C.v..
[102715255]
It was alleged that the copper niti wire fractured at the distal end of fron molar while the patient was eating and patient swallowed the 15-17mm wire. This wire was immediately removed. To date the patient has fully recovered.
Patient Sequence No: 1, Text Type: N, H10
[102715256]
Patient swallowed 15-17mm wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00011 |
| MDR Report Key | 7346747 |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-27 |
| Date of Event | 2018-02-26 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-03-16 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | SDS DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Street | CIRCUITO SUR NO. 31 |
| Manufacturer City | MEXICALI, MEXICO C.P.2139 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 21395 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CUNITI WIRE |
| Generic Name | DAMON COPPER NITI WIRE |
| Product Code | DZC |
| Date Received | 2018-03-16 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SDS DE MEXICO S. DE R.L. DE C.V. |
| Manufacturer Address | CIRCUITO SUR NO. 31 MEXICALI, MEXICO C.P.2139 MX C.P. 21395 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-16 |