FDA.reportPublic FDA data

MAUDE MDR 4085152

MDR report key
4085152
Report number
MW5038151
Event key
0
Event type
3
Date of event
2014-08-10
Date received
2014-09-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
0
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
1KOTEXPANTILINERSKIMBERLYCLARKHHD
2ALWAYSPADPROCTOR & GAMBLEHHD

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-0801. S

Event Narratives#

D

Patient 1

I HAVE BEEN USING PADS AND PANTILINERS FOR THE PAST 10 YEARS AND I HAVE ALWAYS HAD ISSUES WITH PAIN, BURNING, ITCHING, AND BAD RASHES WHEN USING ANY MAJOR PAD OR PANTILINER PRODUCT SUCH AS ALWAYS AND KOTEX. I FINALLY DID MY RESEARCH AFTER THE PAIN AND BURNING GOT SO BAD IT HURT TO WALK. I LEARNED THAT THERE IS SULFUR IN THE PADS AND PANTILINERS AND I AM ALLERGIC TO IT. MY DOCTOR CONFIRMED THIS AND I HAVE SINCE STOPPED USING THIS PRODUCTS AND FOUND ALL ORGANIC ONES WITH NO SULFUR WHATSOEVER AND HAVE BEEN FINE.