MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-05 for RADIONICS RFG-3B TG-15255 manufactured by Radionics.
[16366861]
Radio frequency electrode tip retained below the subcutaneous tissue of left side of face of pt in or. No plans to retrieve tip of electrode.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013008 |
| MDR Report Key | 149484 |
| Date Received | 1998-02-05 |
| Date of Report | 1998-02-04 |
| Date of Event | 1998-01-28 |
| Date Added to Maude | 1998-02-20 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RADIONICS |
| Generic Name | ELECTRODE |
| Product Code | JXO |
| Date Received | 1998-02-05 |
| Model Number | RFG-3B |
| Catalog Number | TG-15255 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 145668 |
| Manufacturer | RADIONICS |
| Manufacturer Address | 76 CAMBRIDGE ST. BURLINGTON MA 01803 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-02-05 |