MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-26 for NEMECTRON EDIT 049 0486-07 manufactured by Nemectron Gmbh.
[12637]
Pt received lumbar electrical treatment. At end of treatment a suspicious redness was noticed, not unlike a burn. 3/3/94 pt came back in office, had small electrical burn. Pt said it is only tender. Physician gave same treatment using less intensity. 3/6/94 physician decided to excise the burn to help heal the area. It looked to him like it would take several weeks heal. Physican recommeded also keflex. Dr continued treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432135-1994-00001 |
| MDR Report Key | 18754 |
| Date Received | 1994-10-26 |
| Date of Report | 1994-09-23 |
| Date of Event | 1992-03-02 |
| Date Facility Aware | 1992-03-04 |
| Report Date | 1994-09-23 |
| Date Reported to FDA | 1994-09-30 |
| Date Reported to Mfgr | 1994-09-30 |
| Date Added to Maude | 1995-01-05 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEMECTRON EDIT |
| Generic Name | ELECTRICAL STIMULATOR |
| Product Code | IPY |
| Date Received | 1994-10-26 |
| Model Number | 049 |
| Catalog Number | 0486-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 18682 |
| Manufacturer | NEMECTRON GMBH |
| Manufacturer Address | DAIMLERS 15 76185 KARLSRUHE GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-10-26 |