MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-02 for DISCOVERY BRACKET UNK manufactured by Dentaurum J.p. Winkelstroeter Kg.
[19493973]
Orthodontist reported that enamel damage occurred on patient's upper right lateral incisor tooth when he debonded discovery brackets. A piece of enamel down to dentin was removed on the tooth. The manufacturer, dentaurum, provides a special instrument to debond discovery brackets. However, the orthodontist reported that he used a pin and ligature cutter to debond the brackets.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2002-00003 |
| MDR Report Key | 391835 |
| Date Received | 2002-05-02 |
| Date of Report | 2002-04-03 |
| Date of Event | 2002-03-02 |
| Date Added to Maude | 2002-05-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISCOVERY BRACKET |
| Generic Name | ORTHODONTIC STAINLESS STEEL BRACKET |
| Product Code | DYW |
| Date Received | 2002-05-02 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 380869 |
| Manufacturer | DENTAURUM J.P. WINKELSTROETER KG |
| Manufacturer Address | TURNSTRASSE 31 ISPRINGEN GM 75228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-05-02 |