FDA.reportPublic FDA data

MAUDE MDR 5895867

MDR report key
5895867
Report number
MW5064245
Event key
0
Event type
3
Date of event
2016-07-15
Date received
2016-08-18
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
1REPLENS LONG LASTING VAGINAL MOISTURIZERREPLENS LONG LASTING VAGINAL MOISTURIZERCHURCH & DWIGHT CO.NUC* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-08-1801. O

Event Narratives#

D

Patient 1

AFTER USING THIS PRODUCT, I FIRST EXPERIENCED WHITE COTTAGE CHEESE DISCHARGE WHICH WAS TO BE EXPECTED BUT THEN IT TURNED INTO BLACK COAL LIKE LUMPS. I STARTED BLEEDING BETWEEN PERIODS AND DEVELOPED BURNING AND ITCHING. ON A VISIT TO MY GYNECOLOGIST, SHE HAD TO REMOVE CLUMPS OF THE PRODUCT BEFORE THE EXAM COULD TAKE PLACE. MUCH OF IT WAS REMOVED BUT SOME STILL REMAINED. EXPERIENCE, BLOATING AND PELVIC PAIN. STILL PASSING BLACK COAL LIKE LUMPS EVEN THOUGH I HAVEN'T USED THE PRODUCT IN OVER TWO MONTHS. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: VAGINAL DRYNESS.