MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for DAMON WIRE manufactured by Ormco Corporation.
[136301356]
It was alleged that the patient managed to break and swallow the damon archwire. The patient passed the archwire naturally and is doing fine to date.
Patient Sequence No: 1, Text Type: N, H10
[136301357]
Patients swallowed a piece of wire while having damon appliance in the mouth. The piece of wire slipped out of the tube. The patient managed to break it and swallowed it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00004 |
| MDR Report Key | 8324183 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-04-26 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-01-31 |
| Date Added to Maude | 2019-02-08 |
| 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 | 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, 21395 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21395 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DAMON WIRE |
| Generic Name | WIRE, ORTHODONTIC |
| Product Code | DZC |
| Date Received | 2019-02-08 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1889 W. MISSION BLVD POMONA CA 91766 US 91766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-08 |