MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for CUNITI WIRE 210-1905 manufactured by Sds De Mexico.
[137005275]
A doctor reported to the (b)(6) distributor that he had wire breakage with being swallowed sometimes. No patient injuries. There was no additional information provided but the product was passed naturally.
Patient Sequence No: 1, Text Type: N, H10
[137005276]
The cuniti wires broke and possibly passed naturally. There were no reportable injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00003 |
| MDR Report Key | 8303289 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-01-13 |
| Date Mfgr Received | 2019-01-13 |
| Date Added to Maude | 2019-02-04 |
| 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 | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1889 W. MISSION BLVD |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal | 91766 |
| Manufacturer Phone | 9096713431 |
| Manufacturer G1 | SDS DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. CIRCUITO SUR NO. 31 |
| Manufacturer City | MEXICALI, MEXICO 21395 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 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 | 2019-02-04 |
| Catalog Number | 210-1905 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SDS DE MEXICO |
| Manufacturer Address | S. DE R.L. C.V. CIRCUITO SUR NO 31 MEXICALI, MEXICO C.P. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-04 |