MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-17 for DAMON CUNITI ARCHWIRE 205-1909 manufactured by Sds De Mexico.
[130536173]
It was alleged that two patients swallowed damon cuniti archwire. It was unknown if the archwires passed through naturally. Doctor stated that the patients are doing fine and "their" are no further issues.
Patient Sequence No: 1, Text Type: N, H10
[130536174]
It was alleged that two patients swallowed the archwires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00060 |
| MDR Report Key | 8170184 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-17 |
| Date of Report | 2018-11-16 |
| Date Mfgr Received | 2018-11-19 |
| Date Added to Maude | 2018-12-17 |
| 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 |
| 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 | 9096713431 |
| Manufacturer G1 | SDS DE MEXICO |
| Manufacturer Street | S. DE R.L. DE C.V. CIRCUITO SUR NO. 31 |
| Manufacturer City | MEXICALI, MEXICO 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 | 2018-12-17 |
| Catalog Number | 205-1909 |
| Lot Number | 091795555,061799338,081765283 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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. DE C.V. CIRCUITO SUR NO. 31 MEXICALI, MEXICO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-17 |