MAUDE Adverse Event Report: LIGHTRELIEF, LLC LIGHT RELIEF

Model Number LR150

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Unspecified Infection (1930); Full thickness (Third Degree) Burn (2696)

Event Date 08/14/2016

Event Type  Death  

Event Description

Sudden death.Took bumex for 8 days as prescribed, he was a border line diabetic male and (b)(6).The medication has no warning on it for sudden death, but reviews show it causes sudden death.He was in perfect athletic condition prior to burning foot with a light device called "light relief".It is infrared light.While he was using the device, it 3rd degree burned his foot and toe, which caused in infection and retention of water in his body and death.He burned his foot with the light on (b)(6) and died on (b)(6) 2016.Dose or amount: 1 tablet, frequency: every 12 hrs, route: taken by mouth, applied to a surface, usually the skin.Event abated after use stopped or dose reduced: no.Dates of use: (b)(6) 2016.Diagnosis or reason for use: the bumex to remove retained water after burn, pain in foot.

• Brand Name: LIGHT RELIEF
• Type of Device: LIGHT RELIEF
• Manufacturer (Section D): LIGHTRELIEF, LLC; los angeles CA 90010
• MDR Report Key: 6085455
• MDR Text Key: 59393775
• Report Number: MW5065873
• Device Sequence Number: 1
• Product Code: ILY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: No Information
• Type of Report: Initial
• Report Date: 11/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LR150
• Device Lot Number: LR150
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ASPIRIN; BUMEX 1MG ; HUMALOG; ONE A DAY VITAMIN
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 66