MAUDE Adverse Event Report: BEMER INT. AG BEMER ; MASSAGER, THERAPEUTIC, ELECTRIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); Reaction (2414)

Event Date 01/12/2020

Event Type  malfunction  

Event Description

Allergy and possible emboli's.Bemer machine caused allergy on my brother.About 20 years ago, i knew shaking vein walls release the vein wall accumulated toxins.I did not know i would get an allergy if the toxins would be released into the blood flow.I did shake the vein walls in my head by passing a hair brush many times.I suddenly got an allergy and got swollen.I went to the emergency room and got antihistamine injections.The bemer machine that you approved as a class 1 medical device works the same way with electromagnetic impulses shaking the vein walls.So i bet this is what caused an allergy on my brother.This machine can also make the vein walls shake away cholesterol trapped in calcium on the vein walls causing major problems for pts.Bemergrou.Com.Fda safety report id# (b)(4).

• Brand Name: BEMER
• Type of Device: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): BEMER INT. AG
• MDR Report Key: 9641774
• MDR Text Key: 177160091
• Report Number: MW5092593
• Device Sequence Number: 1
• Product Code: ISA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other