MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for FISHER WALLACE STIMULATOR manufactured by Fisher Wallace Laboratories.
[28370107]
On (b)(6) 2015, in the morning, used fisher wallace cranial electro stimulator for first (and only) time. Due to the product defuse (lack of safely features), i accidentally kicked the intensity level slide up. Didn't realize it till near end of treatment (at 20min). I was at high level instead of low level. Suffered prompt adverse effects of hyper excitement, then lightheadedness, ringing in ears, inability to concentrate (loss of short-term memory), crawling sensation in my temples. Became very anxious and depression as a result (with pre-existing condition - exacerbated). Have not fully recovered from the adverse symptom. Principally increased depression.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056926 |
| MDR Report Key | 5147879 |
| Date Received | 2015-10-07 |
| Date of Report | 2015-10-07 |
| Date of Event | 2015-06-11 |
| Date Added to Maude | 2015-10-14 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | FISHER WALLACE STIMULATOR |
| Generic Name | FISHER WALLACE STIMULATOR |
| Product Code | JXK |
| Date Received | 2015-10-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FISHER WALLACE LABORATORIES |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2015-10-07 |