MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-02-09 for MYOEXORCISER III UNKNOWN manufactured by Verimed, Inc..
[26852]
Pt seen for speech therapy session. Coma stim provided consisting of oral commands, tactile stimulation to arms, feet, face, hands. Auditory stimulation provided. Emg electrodes placed on pt's face, one above right eyebrow, one on cheekbone below right eye and the other in right temple. Difficulty getting the biofeedback program to work. Eventaully dc/d session. When electrodes were removed skin was broken in the same circle shape under the electrode above the eye, blackened in a circle below the eye and blistered on the temple beside the eye. Physician treated with silvadene cream and later changed to neosporin ointment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32117 |
| MDR Report Key | 32117 |
| Date Received | 1996-02-09 |
| Date of Report | 1995-12-15 |
| Date of Event | 1995-12-06 |
| Date Facility Aware | 1995-12-06 |
| Report Date | 1995-12-15 |
| Date Reported to Mfgr | 1995-12-15 |
| Date Added to Maude | 1996-04-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYOEXORCISER III |
| Generic Name | EMG BIOFEEDBACK DEVICE |
| Product Code | HCC |
| Date Received | 1996-02-09 |
| Returned To Mfg | 1995-12-15 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 33365 |
| Manufacturer | VERIMED, INC. |
| Manufacturer Address | 11950 NW 39TH ST, STE D CORAL SPRINGS FL 33065 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-02-09 |