MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-15 for DAMON TMA 227-1111 manufactured by Ormco Corporation.
[57556952]
It was alleged that a patient had an allergic reaction to damon tma wire. Attempts are being made to get further information will send an update.
Patient Sequence No: 1, Text Type: N, H10
[57556953]
It was alleged that a patient had an allergic reaction to damon tma wires. Attempts are being made to get further information and will send an update.
Patient Sequence No: 1, Text Type: D, B5
[58363283]
It was alleged that a patient had an allergic reaction to damon tma wire. Patient was sent to the er for treatment of allergic reaction. Tma wires were removed and replaced with stainless steel wires. To date the patient has recovered and doing fine.
Patient Sequence No: 1, Text Type: N, H10
[58363284]
It was alleged that a patient had an allergic reaction to damon tma wires.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2016-00005 |
| MDR Report Key | 6031845 |
| Date Received | 2016-10-15 |
| Date of Report | 2016-10-11 |
| Date of Event | 2016-10-10 |
| Date Mfgr Received | 2016-10-14 |
| Date Added to Maude | 2016-10-15 |
| 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 | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal | 91740 |
| Manufacturer Phone | 9099625730 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVE. |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAMON TMA |
| Generic Name | DAMON TMA |
| Product Code | DZC |
| Date Received | 2016-10-15 |
| Catalog Number | 227-1111 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVE. GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-15 |