MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-08-23 for G.E.D. DEVICE ELECTRIC SHOCK DEVICE manufactured by Behavioral Research Institute.
[15487291]
Rptr has received several reports of incidents involving unintentional discharges of the device which residents of the program wear and which is used to apply an electric shock as aversive treatment. Two of these allegations have been investigated, resulting in conclusions that, in fact, the device had misfired due to a malfunction. Both investigation concluded that the resident wearing the device received electrical shocks as a result of the malfunction. In one of the cases, the shocks were found to have caused two ring-shaped marks and three areas of rough skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000758 |
| MDR Report Key | 24869 |
| Date Received | 1995-08-23 |
| Date Added to Maude | 1995-08-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | G.E.D. DEVICE ELECTRIC SHOCK DEVICE |
| Generic Name | ELECTRIC SHOCK DEVICE |
| Product Code | HCB |
| Date Received | 1995-08-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 25291 |
| Manufacturer | BEHAVIORAL RESEARCH INSTITUTE |
| Manufacturer Address | PROVIDENCE RI 02909 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-08-23 |