FDA.reportPublic FDA data

MAUDE MDR 5553767

MDR report key
5553767
Report number
MW5061520
Event key
0
Event type
3
Date of event
2015-05-23
Date received
2016-04-01
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
1KY BRAND MARQUE WARMING LIQUIDKY JELLY WARMING LIQUIDKMJ* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-010

Event Narratives#

D

Patient 1

I, ALONG WITH MY BOYFRIEND, WENT AWAY FOR A WEEKEND. I USED KY JELLY WARMING LIQUID. WELL, THAT WAS THE BEGINNING OF ONE OF THE WORST WEEKS IN MY LIFE AND ALSO THE WRECKING OF THE WEEKEND. FIRST, I CALLED AND THE PERSON I HAD TO SPEAK WITH WAS RUDE, DISINTERESTED, AND SAID THERE WAS NOTHING THAT SHE COULD DO. I ASKED TO SPEAK WITH THE MANGER IN CHARGE, SHE SAID SHE WAS THAT PERSON. I CONTACTED ATTORNEY (B)(6) TO REPRESENT ME AND HE SPOKE WITH (B)(6); REF: (B)(4). I HAVE TRIED TO CONTACT (B)(6) MYSELF BUT TO NO AVAIL. I'VE SUBSEQUENTLY TEXTED AND CALLED ATTORNEY (B)(6) AND HE HASN'T RESPONDED, WHICH LEAVES ME TO ASSUME HE DOESN'T HAVE ANY UPDATES. ALL INFO HAS BEEN FORWARDED VIA ATTORNEY TO KY (AS PER ATTORNEY). REASON FOR USE: DRYNESS. IS THE PRODUCT OVER THE COUNTER: YES; EVENT ABATED AFTER USE, STOPPED OR DOSE REDUCED: NO.