MAUDE Adverse Event Report: BEMER BEMER; MASSAGER, THERAPEUTIC, ELECTRIC

Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/03/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Bemer is marketed as a device that increases blood microcirculation.I initially tried it to help my age related macular degeneration and my vision improved.I bought a unit and treated my erectile dysfunction because that also was supposedly helped.Because cancers increase need for blood flow and i have a known prostate nodule i repeatedly asked my distributor, her up line superior and the national marketing director for evidence that bemer did not create or accelerate cancer growth.They said that bemer actually helps cancers because it increases lymphocyte activity.Bemer was being investigated by md anderson for cancer treatment even now.However, my search of pub med was unsuccessful.All three persons said that bemer has fda level 1 approval and cannot be used to treat specific conditions, just generalized conditions such as not feeling well, sleep and energy.However there is research from europe where the fda equivalent authority has granted higher level approval (which they could not show me) and (b)(6) has lots of testimonials (i was given address).If i still wanted more information, contact bemer (b)(4).I had been following my psa at short intervals and for the last year and a half it was unchanged to marginally lower.Once i started bemer it began to rise.I repeated checking psa to rule out lab error.Same lab, same conditions.Tests were consistent (see next window).Psa started rising as soon as i started bemer treatment and when i stopped the rate of increase slowed- more as the period lengthened from time i stopped.Because my psa was approaching 10, i sought urologic consultation both at u of (b)(6) and also at (b)(6) where i completed my medical residency.Both agreed i should have biopsy even though psa was less in 10.I did and results were 7 of 12 cores were gleason 9 with 80-90% of tissue frank cancer- the others gleason 7.I had urologic/oncologic consultation at both institutions even though imaging did not show mets, i had a 80% chance of having them.I had a extremely aggressive cancer- beyond surgery.Both recommended androgen reduction treatment plus radiation not only of prostate but also locally to the lymph nodes.Currently i am 4 months into art and have had 18 or 40 radiation treatments.I did call dr.(b)(6) after sending him my lab reports and situation report.It turns out he is a naturopathic doctor and unaware of the meaning of gleason scores and unaware that urologists treat prostate cancers unless they are very advanced he had no information about bemer safety.He also told that there are naturopathic remedies that could help.I have already reported him to the (b)(6) authorities including the medical board.

• Brand Name: BEMER
• Common Device Name: MASSAGER, THERAPEUTIC, ELECTRIC
• Manufacturer (Section D): BEMER
• MDR Report Key: 6297796
• Report Number: MW5067617
• Device Sequence Number: 15459606
• Product Code: ISA
• Initial Reporter State: NM
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 01/31/2017

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
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2017
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LISINOPRIL 2.5MG/D ; METFORMIN 500MG BID (NOT DIABETIC,; OTC MEDS: MULTIVI AREDS BID.; RX MEDS: LEVOTHROXIN 125 MICROGRAMS DAILY; TO HEAD OF DEMENTIA MAYBE)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Weight: 81