MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-12-31 for STIMUPLUS PRO UNK manufactured by Solar Wide, Inc..
[36781]
"the device is not approved by the fda and it is dangerous. " the grounding device on rptr's unit was missing so that when the device was activated it sent an electrical shock through the hand that was holding it. The distributor told the rptr that the grounding device was not necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1010488 |
| MDR Report Key | 59411 |
| Date Received | 1996-12-31 |
| Date of Report | 1996-12-30 |
| Date of Event | 1996-12-01 |
| Date Added to Maude | 1997-01-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| 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 | STIMUPLUS PRO |
| Generic Name | ELECTROTHERAPEUTIC STIMULATOR |
| Product Code | GZI |
| Date Received | 1996-12-31 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 59836 |
| Manufacturer | SOLAR WIDE, INC. |
| Manufacturer Address | 245 CARLTON TR TEANECK NJ 07666 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-12-31 |