FDA Adverse Event Other Summary report: N

K-Y WARMING ULTRAGEL

MDR report key: 804736 · Received January 4, 2007

Report

Report Number
2214133-2007-00001
Event Type
Other
Date Received
January 4, 2007
Date of Event
December 1, 2006
Manufacturer
KIK CUSTOMS PRODUCTS
Product Code
MMS
Adverse Event
Yes
Report Source
Distributor report
Reporter Location
US
Reporter Occupation
UNKNOWN

Narratives

Description of Event or Problem · 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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 K-Y WARMING ULTRAGEL PERSONAL LUBRICANT MMS KIK CUSTOMS PRODUCTS NA 0054C

Patients

Seq Age Sex Outcome Treatment
1 33 YR Other