LIGHT SOURCE PAIN RELIEF B347LTSRCEOP 109 857563004644

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for LIGHT SOURCE PAIN RELIEF B347LTSRCEOP 109 857563004644 manufactured by Unk.

Event Text Entries

[140613046] The product does not work to retrieve pain that it states it does. The lights came on but there's no heat. Also not fda cleared as stated. No one can find record of it. Under false pretense of neuropathy treatment. Free dinner at seminar. Have to go into office for appt or will charge for food. Get tested and one week later come back for results. They say to everyone that they have neuropathy. Taking the elderly pts for (b)(6), machines do not work on me, plus don't have this condition that they tried to make me "believe" which i did after they got done talking to me. I was lied to from the beginning. Started treatment that min. These machines do not work, they use a scam to get people's money per my drs. The office diagnosed 3 other (son, myself and husband) with neuropathy which we don't have per 4 of my drs. Went and had chiropractor, podiatrist, primary, and neurologist test me who specializes in neuropathy. All within two months of each other from (b)(6) 2018. Foot pain due to bone spur and tendonitis not neuropathy as stated from optimal health under false pretense of diagnosing. Office over "bogus" hot / cold test to get outcome. Had treatment using them from (b)(6) 2018 to (b)(6) 2018. No results. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085299
• MDR Report Key: 8460773
• Date Received: 2019-03-27
• Date of Report: 2019-03-13
• Date of Event: 2018-08-24
• Date Added to Maude: 2019-03-28
• 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
• 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: 0

Device Details

• Brand Name: LIGHT SOURCE PAIN RELIEF
• Generic Name: HOME THERAPY TREATMENT ELECTRO THERAPY LIGHT PAD SYSTEM
• Product Code: ILY
• Date Received: 2019-03-27
• Returned To Mfg: 2018-11-23
• Model Number: B347LTSRCEOP 109
• Catalog Number: 857563004644
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-27