MAUDE Adverse Event Report: LIGHT SOURCE PAIN RELIEF; HOME THERAPY TREATMENT ELECTRO THERAPY LIGHT PAD SYSTEM

Model Number B347LTSRCEOP 109

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 08/24/2018

Event Type  malfunction  

Event Description

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).

• Brand Name: LIGHT SOURCE PAIN RELIEF
• Type of Device: HOME THERAPY TREATMENT ELECTRO THERAPY LIGHT PAD SYSTEM
• MDR Report Key: 8460773
• MDR Text Key: 140613046
• Report Number: MW5085299
• 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: Patient
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2019
• Device Model Number: B347LTSRCEOP 109
• Device Catalogue Number: 857563004644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 122