FDA.reportPublic FDA data

MAUDE MDR 1276183

MDR report key
1276183
Report number
MW5009478
Event key
0
Event type
3
Date of event
2008-12-07
Date received
2008-12-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1EAR CANDLELOCAL HEALTH FOOD STOREJYH N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-12-3001. H; 2. S

Event Narratives#

D

Patient 1

USED "EAR CANDLE" FROM HEALTH FOOD STORE. WAX DRIPPED INTO MY EAR CAUSING BURNING & WAX BLOCKED MY EARDRUM. EXPERIENCED SEVERE PAIN & IMPAIRED HEARING. I USED THIS PRODUCT PER PACKAGE INSTRUCTIONS. DEFECTIVE PRODUCT CAUSED HOT WAS TO ENTER MY EAR CANAL - BURNING AND BLOCKAGE RESULTED. PRESCRIPTION EAR DROPS 2008. EAR FLUSH PERFORMED BY RN AND Z-PACK ANTIBIOTIC PRESCRIBED FIVE DAYS LATER. OUT PT SURGERY TO REMOVE BLOCKAGE IN THE SAME MONTH. DOSE OR AMOUNT: 1 CANDLE PER EAR. FREQUENCY: ONCE. ROUTE: DATES OF USE: 2008.(1 TIME ONLY). REASON FOR USE: CLEAN EARS. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.