MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2002-02-19 for SOMNUS UNK manufactured by Gyrus Ent Llc.
[18330864]
It was reported in the journal otolaryngology-head and neck surgery volume 125, number 5, occult mucosal injuries with radiofrequency ablation of the palate that though intended to be mucosa-sparing, radiofrequency ablation of the palate (rfap) is nevertheless associated with a high incidence of mucosal injuries, many of which are occult.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037007-2002-00001 |
| MDR Report Key | 377936 |
| Report Source | 03 |
| Date Received | 2002-02-19 |
| Date of Report | 2002-02-18 |
| Date Mfgr Received | 2002-01-30 |
| Date Added to Maude | 2002-02-25 |
| 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 | 3 |
| Manufacturer Contact | MR. GREG SREDIN, SR SPC. |
| Manufacturer Street | 2925 APPLING RD |
| Manufacturer City | BARTLETT TN 38133 |
| Manufacturer Country | US |
| Manufacturer Postal | 38133 |
| Manufacturer Phone | 9013730200 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOMNUS |
| Generic Name | RADIO FREQUENCY GENERATOR |
| Product Code | GEJ |
| Date Received | 2002-02-19 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 366983 |
| Manufacturer | GYRUS ENT LLC |
| Manufacturer Address | 2925 APPLING ROAD BARTLETT TN 38113 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-02-19 |