MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-28 for BEMER manufactured by Bemer Int. Ag.
[177160091]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092593 |
| MDR Report Key | 9641774 |
| Date Received | 2020-01-28 |
| Date of Report | 2020-01-26 |
| Date of Event | 2020-01-12 |
| Date Added to Maude | 2020-01-29 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 3 |
| Brand Name | BEMER |
| Generic Name | MASSAGER, THERAPEUTIC, ELECTRIC |
| Product Code | ISA |
| Date Received | 2020-01-28 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEMER INT. AG |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-28 |