MAUDE Adverse Event Report: TESLA BIOHEALING, INC. TESLA MEDBED GENERATOR; LAMP, INFRARED, THERAPEUTIC HEATING

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

Patient Problems Inadequate Pain Relief (2388); Unspecified Gastrointestinal Problem (4491)

Event Date 02/17/2024

Event Type  Death  

Event Description

I claim i purchased your 2 tesla biohealers on (b)(6) 2021, order (b)(4).I claim i had several conversations with (b)(4) regarding all my mom¿s (b)(6) medical conditions i was hopeful results would occur.When we started, she had already been through micro-chronic strokes, along with 3 other larger strokes.She had lost the vision in her left eye.She had an abdominal aortic aneurysm at 4.7 cm that grew to 6.8 cm over a 3-year period which no one would do surgery because she was also diagnosed with dementia in 2020.They felt the dementia would get worse faster if they did the open surgery on her aaa.In 2020, my mom also started getting tremors in her right hand and having some issues with walking stable on her own.I claim we received the med beds with no issue.My mom used them for several months with hopes of her memory coming back some.The big hope was that nothing more would grow and the small issues would go away.I had hoped her tremors and balance issues would resolve and that her short term memory would start to come back.Nothing ever happened.I claim i spoke with you over the phone on october 9, 2021.You stated to put one device under her bed and one device next to her head on the nightstand.We did that with no improvement.I claim on september of 2023, i decided to send a response via email to ask how these are even worth the cost? i received a response from (b)(4) who had zero input into the workings of these medbeds.Nothing good happened to my mom, she even had stomach issues and had her gall bladder removed (b)(6) 2021 which was after we purchased the biohealers.Her aaa never got better, it got worse.Her dementia never got better it got worse.Her parkinson's symptoms never got better either.Then in 2023 my dad also was diagnosed with prostate cancer and he was sleeping in the same bed.My mother passed away (b)(6) 2024.I claim the 2 tesla biohealers are nothing but fraud.I claim i submitted 2 reviews on the website, 3/10/23 and 9/13/23 both included my negative review and neither are currently on your website any longer.I got the judge.Me confirmation and clicked the link.I claim today you can see zero bad reviews on your product on your website.I claim this is fraudulent and deceitful for your current and potential customers.I claim i found a letter online last year about a warning from the fda! i spoke to the representative listed at the bottom and she stated she has had several phone calls based on this fda letter and that the warning has not been resolved.See link: tesla biohealing, inc.- (b)(4)- 08/10/2023 | fda.I claim you are scamming people who just want to save their loved ones and are in a vulnerable state.I claim i was willing to spend whatever i needed to try and heal my mom.I claim you and your company took advantage of the need to help heal my mom and my vulnerable state.I require full return of purchased price paid of (b)(6).I require my two reviews be published on your website.If i do not receive responses and actions to my specific asks and requirements within fifteen (15) days, as requested shall constitute your explicit, binding and complete tacit agreement as your unequivocal acceptance by yourself and your organization and will pursue all appropriate remedies available to hold you and your company commercially and personally liable.It is my duty as an american to keep the peace and uphold the public law.And i object to evil.Reference report mw5165613.

Event Description

Additional information received on 2/6/2025 for report number mw5165614.Reference report number mw5165613 and mw5165613_1.

• Brand Name: TESLA MEDBED GENERATOR
• Type of Device: LAMP, INFRARED, THERAPEUTIC HEATING
• Manufacturer (Section D): TESLA BIOHEALING, INC.
• MDR Report Key: 21304929
• MDR Text Key: 362856256
• Report Number: MW5165614
• Device Sequence Number: 1
• Product Code: ILY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2025

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/04/2025
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/06/2025
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Unknown