MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-04-26 for DAMON CUNITI ARCHWIRE 205-1909 manufactured by Sds De Mexico.
[143388806]
It was alleged that two patients swallowed the archwires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00009 |
| MDR Report Key | 8557393 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-04-26 |
| Date of Report | 2019-04-26 |
| Date of Event | 2018-11-16 |
| Date Mfgr Received | 2018-11-16 |
| Date Added to Maude | 2019-04-26 |
| 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 AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9096713431 |
| Manufacturer G1 | SDS DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. CIRCUITO SUR NO. 31 |
| Manufacturer City | MEXICALI, MEXXICO C.P. 21395 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21395 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAMON CUNITI ARCHWIRE |
| Generic Name | DAMON CUNITI ARCHWIRE |
| Product Code | DZC |
| Date Received | 2019-04-26 |
| Catalog Number | 205-1909 |
| Lot Number | 091795555,061799338,081765283 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SDS DE MEXICO |
| Manufacturer Address | S. DE R.L. DE C.V. CIRCUITO SUR NO. 31 MEXICALI, MEXICO 21395 MX 21395 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-26 |