FDA.reportPublic FDA data

MAUDE MDR 6085455

MDR report key
6085455
Report number
MW5065873
Event key
0
Event type
3
Date of event
2016-08-14
Date received
2016-11-05
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIGHT RELIEFLIGHT RELIEFLIGHTRELIEF, LLCILYLR150LR150* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-0501. D

Event Narratives#

D

Patient 1

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.