FDA Adverse Event
Injury
Summary report: N
BEMER CLASSIC PRO SET
MDR report key: 6157919
·
Received December 7, 2016
Report
- Report Number
- MW5066609
- Event Type
- Injury
- Date Received
- December 7, 2016
- Date of Event
- February 1, 2016
- Report Date
- December 7, 2016
- Manufacturer
- BEMER INC AG
- Product Code
- ISA
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 800998 | BEMER CLASSIC PRO SET | PHYSICAL VASCULAR THERAPY | ISA | BEMER INC AG | UNK | 740213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Disability | ALPHA-LIPOIC ACID 600| B-SUPREME| DETOX 2 HERBAL SUPPLEMENT| INFLAMMATONE | MAGNESIUM MALATE| OTC MEDS: TUMERIC| RX MEDS: NEURONTIN| ULTRA B12-FOLATE |