MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2015-06-24 for INSIGNIA 3919598*1*1 manufactured by Ormco Corporation.
[17215803]
A doctor alleged that the insignia jig did not fit; therefore, he removed the brackets from the jig and placed them manually.
Patient Sequence No: 1, Text Type: D, B5
[17421068]
Specific patient information with regard to age and weight was not provided. A doctor alleged that the insignia jig did not fit; therefore he removed the brackets from the jig and placed them manually. The patient will return for removal of the brackets and a new insignia kit will be created and placed. The device was received in a condition which made analysis impossible; therefore, no further evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2015-00019 |
| MDR Report Key | 4865176 |
| Report Source | 00,05 |
| Date Received | 2015-06-24 |
| Date of Report | 2015-05-27 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-07-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 1332 S. 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 AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSIGNIA |
| Generic Name | ORTHODONTIC PLASTIC BRACKET |
| Product Code | DYW |
| Date Received | 2015-06-24 |
| Catalog Number | 3919598*1*1 |
| Lot Number | 75940 |
| Operator | OTHER |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-06-24 |