FDA.reportPublic FDA data

MAUDE MDR 6060242

MDR report key
6060242
Report number
MW5065644
Event key
0
Event type
3
Date of event
2016-10-23
Date received
2016-10-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1KY JELLY PERSONAL LUBRICANTKY JELLY PERSONAL LUBRICANTRECKITT BENCKISERNUC619752* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-10-2601. O

Event Narratives#

D

Patient 1

BURNING RASH AND PAIN IN GENITALS WHERE PRODUCT WAS USED. SYMPTOMS ARE WORSE WHEN CONTINUED USE. I HAVE USED THE SAME BRAND PRODUCT LUBRICANT (B)(4) LIQUID FOR YEARS WITH NO PROBLEMS UNTIL I USED THIS SLIGHTLY DIFFERENT PRODUCT (B)(4). NOW I AM HAVING A RASH THAT IS CONTINUALLY BURNING IF I KEEP USING IT. RASH DISCOMFORT ALLERGIC REACTION. HOW WAS IT TAKEN OR USED: VAGINAL. DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT? NO. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN? YES. SEX INTIMACY.