inforMED
DeathMMS

K-Y WARMING LIQUID

Received Mar 7, 2005 · Event occurred Dec 1, 2004

Report 2214133-2005-00001 · MDR key 580399

Device

Generic name

Personal Lubricant

Model number

NA

Catalog number

NA

Lot number

UNK

Product problems

  • Unknown (for use when the device problem is not known)

Patient

UNKNOWN

  • Bleeding
  • Death
  • Miscarriage
  • Burning Sensation

Narrative

Description of Event or Problem

CONSUMER INFO CENTER NOTIFIED VIA INTERNET FROM J&J AFFILIATE THAT CONSUMER RANG UP TO SAY THAT DURING DECEMBER WHILE THEY WERE PREGNANT THEY HAD USED A SAMPLE OF K-Y WARMING LIQUID WHICH COMPANY HAD SENT TO THEM. THEY SAID THAT AFTER USING THE PRODUCT DURING INTERCOURSE THEY EXPERIENCED A BURNING SENSATION AND LATER THAT NIGHT HAD STARTED TO BLEED. THREE DAYS LATER THEY HAD A MISCARRIAGE. REP ASKED IF THEIR DOCTOR HAD BEEN ABLE TO GIVE AN OPINION AS TO WHY THEY HAD MISCARRIED AND THEY SAID THAT THE DRS WERE UNABLE TO GIVE A SPECIFIC REASON. THEY SAID THAT THEY ARE CONVINCED THAT THE K-Y WARMING LIQUID HAD CAUSED THE MISCARRIAGE AND THEY WERE DETERMINED TO GO PUBLIC AND INFORM EVERYONE THAT THIS PRODUCT SHOULD NOT BE USED DURING PREGNANCY. THEY SAID THAT IT HAD TAKEN THEM SOMETIME TO CONTACT CO AS THEY STILL HAD DIFFICULTY IN ACCEPTING THE LOSS OF THEIR BABY. THEY ENDED THE CONVERSATION BY SAYING THEY WOULD WAIT TO HEAR FROM THE COMPANY.