MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-05-25 for FISHER WALLACE CES manufactured by Fisher Wallace Laboratories Llc.
[1200314]
Use of ces by company caused long lasting headache, deepening of minor depression to the point of despair, undue sleepiness with desire to nod off while driving. The device was used as directed for 3 days only. Sluggish during the day has persisted much to my dismay. These symptoms occurred abruptly and have persisted. Frequency: qd. Route: other. Dates of use: 2009. Diagnosis or reason for use : to treat depression/anxiety/pain. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5011219 |
| MDR Report Key | 1393846 |
| Date Received | 2009-05-25 |
| Date of Report | 2009-05-25 |
| Date of Event | 2009-05-10 |
| Date Added to Maude | 2009-06-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FISHER WALLACE CES |
| Generic Name | CES, 20 MINUTE TREATMENT QD |
| Product Code | JXK |
| Date Received | 2009-05-25 |
| Returned To Mfg | 2009-05-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER WALLACE LABORATORIES LLC |
| Manufacturer Address | 515 MADISON AVE SUITE 5W NEW YORK NY 10022 US 10022 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-05-25 |