MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-05 for CUNITI WIRE 210-1905 manufactured by Sds De Mexico.
| Report Number | 2016150-2019-00013 |
| MDR Report Key | 8672042 |
| Date Received | 2019-06-05 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-05-22 |
| Date Mfgr Received | 2019-07-03 |
| Date Added to Maude | 2019-06-05 |
| 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 | MR. RANDY KNUCKLES |
| Manufacturer Street | 1889 W. MISSION BLVD |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal | 91766 |
| Manufacturer Phone | 9096713444 |
| Manufacturer G1 | SDS DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. CIRCUITO SUR NO. 31 |
| Manufacturer City | MEXICALI, MEXICO |
| 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 | 2019-06-05 |
| Catalog Number | 210-1905 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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, 21395 MX 21395 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-06-05 |