MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-11-17 for VICTORY SERIES NARROW CONTOURED MICROETCHED BAND 902-177 manufactured by 3m Unitek.
[431442]
Orthodontic band broke when pt bit into a piece of bread in 2005. Three days later an orthodontist removed the upper bands from the pt's mouth and confirmed infection in pt's mouth near the area of the broken band. The following day pt visited a hosp clinic and was given prescriptions for amoxicillin (antibiotic) and tramadol (non-narcotic pain reliever). Pt has recovered from the infection and is continuing with his orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2005-00007 |
| MDR Report Key | 647468 |
| Report Source | 05 |
| Date Received | 2005-11-17 |
| Date of Report | 2005-10-21 |
| Date of Event | 2005-07-06 |
| Date Mfgr Received | 2005-10-21 |
| Date Added to Maude | 2005-11-28 |
| 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 | 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 | VICTORY SERIES NARROW CONTOURED MICROETCHED BAND |
| Generic Name | ORTHODONTIC METAL BAND |
| Product Code | ECM |
| Date Received | 2005-11-17 |
| Model Number | NA |
| Catalog Number | 902-177 |
| 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 | 636956 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | VICTORY SERIES NARROW CONTOURED MICROETCHED BAND |
| Baseline Generic Name | ORTHODONTIC METAL BAND |
| Baseline Model No | NA |
| Baseline Catalog No | 902-177 |
| Baseline Device Family | NARROW MOLAR BAND |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-17 |