MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-12-22 for FISHER WALLACE STIMULATOR FW100 DEVICE NOT RETURNED manufactured by Fisher-wallace Laboratories Llc.
[21349716]
The pt / person who filed this report with the fda never returned the device to the mfr (or if they did, he/she never identified the adverse event in connection with their return, making device eval impossible). The pt reaction described in the report may be deemed a "paradoxical response. " determining if the device contributed to the symptoms requires much more info about the case, including other treatments the pt was receiving at the time, diagnosis, history, and past conditions. The info provided in the report is insufficient to determine if the reported symptoms are attributable to the use of the device. The pt may have had a condition that was not appropriately diagnosed for which the device, or other anti-anxiety treatments, was not indicated.
Patient Sequence No: 1, Text Type: N, H10
[21418392]
.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006258094-2011-00001 |
| MDR Report Key | 2475545 |
| Report Source | 00 |
| Date Received | 2011-12-22 |
| Date of Report | 2011-09-30 |
| Date Mfgr Received | 2011-11-21 |
| Date Added to Maude | 2012-07-27 |
| 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 | KELLY ROMAN, VICE PRESIDENT |
| Manufacturer Street | 515 MADISON AVE., FL 22 |
| Manufacturer City | NEW YORK NY 10022 |
| Manufacturer Country | US |
| Manufacturer Postal | 10022 |
| Manufacturer Phone | 2126888100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FISHER WALLACE STIMULATOR |
| Generic Name | CES DEVICE |
| Product Code | JXK |
| Date Received | 2011-12-22 |
| Model Number | FW100 |
| Catalog Number | DEVICE NOT RETURNED |
| Lot Number | DEVICE NOT RETURNED |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER-WALLACE LABORATORIES LLC |
| Manufacturer Address | NEW YORK NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-12-22 |