MAUDE MDR 804736

MDR report key
804736
Report number
2214133-2007-00001
Event key
0
Event type
3
Date of event
2006-12-01
Date received
2007-01-04
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
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1K-Y WARMING ULTRAGELPERSONAL LUBRICANTKIK CUSTOMS PRODUCTSMMSNANA0054CNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-01-0401. O

Event Narratives#

D

Patient 1

CONSUMER REPORTED: AFTER USE OF PRODUCT, CONSUMER SUFFERED FROM A MISCARRIAGE. CONSUMER IS UNSURE IF IT IS PRODUCT RELATED. "I UTILIZED YOUR PRODUCT DURING PREGNANCY BECAUSE OF THE EXTREME DRYNESS, AND ALSO TO ASSIST WITH INTERCOURSE IN THE CASE OF DRYNESS. I UTILIZED THE PRODUCT FREQUENTLY WITH SATISFACTION. TO MAKE A LONG STORY SHORT, I LOST MY BABY AND DOCTORS COULD NOT FIND ONE REASON WHY A PERFECT PREGNANCY TURNED. I WAS QUESTIONED OVER AND OVER ABOUT IF THERE WAS ANY PRODUCTS OR MEDS USED THAT THE DR OR HOSP STAFF WAS UNAWARE OF THAT COULD HAVE POSSIBLY CAUSED THE UNFORTUNATE SITUATION, I WAS TOO EMBARRASSED TO MENTION TO THEM OR MY HUSBAND THAT I HAD TO USE THE PRODUCT. BUT, IN THE BACK OF MY MIND -- ONLY BECAUSE THE PRODUCT LABEL MENTIONS NO SIDE EFFECTS HAVE BEEN RECORDED OR STUDIES ON THE EFFECTS OF USE WHILE PREGNANT, I WONDER IF THIS COULD HAVE BEEN A POSSIBLE SIDE EFFECT. I MEAN IF NO ONE EVER MENTIONS IT, HOW COULD IT? I JUST WANT TO KNOW SO THAT NEXT TIME A DIFFERENT PRODUCT WILL BE USED OR SO OTHERS DON'T HAVE TO GO THROUGH WHAT I DID, IF THE PRODUCT IS A POSSIBLE DANGER TO A FETUS, OR CAN CAUSE WHAT IT DID IN MY SITUATION. PLEASE CHECK INTO IT TO SEE - DON'T LET OTHERS GO THROUGH THIS. I AM NOT UPSET, JUST WANT OTHERS TO BE WARNED IF THE PRODUCT IS A POTENTIAL HAZARD. NO ADDITIONAL INFO AVAILABLE AT THIS TIME.