MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-07 for BEMER CLASSIC PRO SET UNK manufactured by Bemer Inc Ag.
[62128486]
Within a month of purchasing and using the bemer class/pro electromagnetic vascular therapy mat and accessories i developed numb fingers, cramping and charlie horses in my legs and stiff legs with uncoordinated climbing of stairs and walking; all of which have persisted since then.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066609 |
| MDR Report Key | 6157919 |
| Date Received | 2016-12-07 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-02-01 |
| Date Added to Maude | 2016-12-09 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | BEMER CLASSIC PRO SET |
| Generic Name | PHYSICAL VASCULAR THERAPY |
| Product Code | ISA |
| Date Received | 2016-12-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | 740213 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEMER INC AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-12-07 |