MAUDE Adverse Event Report: BEMER INC AG BEMER CLASSIC PRO SET; PHYSICAL VASCULAR THERAPY

Lot Number 740213

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Muscle Spasm(s) (1966); Cramp(s) (2193); Numbness (2415)

Event Date 02/01/2016

Event Type  Injury  

Event Description

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.

• Brand Name: BEMER CLASSIC PRO SET
• Type of Device: PHYSICAL VASCULAR THERAPY
• Manufacturer (Section D): BEMER INC AG
• MDR Report Key: 6157919
• MDR Text Key: 62128486
• Report Number: MW5066609
• Device Sequence Number: 1
• Product Code: ISA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 740213
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALPHA-LIPOIC ACID 600; B-SUPREME; DETOX 2 HERBAL SUPPLEMENT; INFLAMMATONE ; MAGNESIUM MALATE; OTC MEDS: TUMERIC; RX MEDS: NEURONTIN; ULTRA B12-FOLATE
• Patient Outcome(s): Disability
• Patient Age: 62 YR
• Patient Weight: 77