FDA.reportPublic FDA data

MAUDE MDR 5684509

MDR report key
5684509
Report number
MW5062508
Event key
0
Event type
3
Date of event
2016-04-30
Date received
2016-05-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
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
1SOUND BODYQ-TIPSFILO AMERICAKXF8723* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-240

Event Narratives#

D

Patient 1

CONSUMER STATED THAT THE COTTON TIPS OF THE Q-TIP CAME OFF IN HIS EAR CANAL AND HE HAD TO DIG IT OUT. HE STATED THE WARNING STATED THAT HE SHOULD SWAB AROUND THE EAR DRUM NOT TO BE USED IN THE EAR CANAL. HE FEELS THAT THE Q-TIP IS MISLEADING BECAUSE IT SHOULD BE USED TO CLEAN OUT THE EAR DRUMS. INJURY INFORMATION: INJURY, LEVEL OF CARE NOT KNOWN. RETAILER: (B)(6). RETAILER STATE: (B)(6). THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. DOCUMENT NUMBER: (B)(4), REPORT NUMBER: (B)(4).