FDA.reportPublic FDA data

MAUDE MDR 7705777

MDR report key
7705777
Report number
MW5078481
Event key
0
Event type
3
Date of event
2016-03-01
Date received
2018-07-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1POISE PADS LONG LENGTHGARMENT, PROTECTIVE FOR INCONTINENCEKIMBERLY CLARK CORPEYQI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-1901. S

Event Narratives#

D

Patient 1

HAVE BEEN USING POISE INCONTINENCE PADS. DEVELOPED EXTREMELY ITCHY RASH WHERE PAD TOUCHES - LOWER ABDOMEN TO ABOVE ANUS (LONG LENGTH PADS). THOUGHT AT FIRST IT WAS A VAGINAL YEAST INFECTION, BUT I HAD NO ITCHING INSIDE VAGINA; ONLY EXTERNALLY. INTENSE ITCHING. FINALLY STOPPED USING PADS. THE NEXT DAY, ITCHING STARTED DECREASING. LOOKED IT UP ON THE INTERNET. COMPLAINTS GOING BACK TO 2014. IS THIS PRODUCT OVER THE COUNTER? YES.