OtherFHX

SCHEIN STERILE LUBRICATING JELLY 4 OZ. TUBE

Received Aug 25, 2010 · Event occurred Feb 9, 2010

Report 2128643-2010-00001 · MDR key 1819564

Device

Generic name

Lubricating Jelly

Manufacturer

Triad Group, Inc.

Lot number

9B121

Product problems

Insufficient Device Problem Information

Patient

Not reported

Irritation

Narrative

Additional Manufacturer Narrative

WHEN USING SCHEIN STERILE LUBRICATING JELLY, 4 OZ. TUBE, LOT 9B121, OVER 30 PTS COMPLAINED OF VAGINAL IRRITATION. ALL PTS WERE PRESCRIBED A MEDICATED OINTMENT. UPON USING THE PRESCRIBED MEDICATED OINTMENT, THE SYMPTOMS HAVE RESOLVED.

Description of Event or Problem

WHEN USING SCHEIN STERILE LUBRICATING JELLY, 4 OZ. TUBE, LOT 9B121, OVER 30 PTS COMPLAINED OF VAGINAL IRRITATION. ALL PTS WERE PRESCRIBED A MEDICATED OINTMENT.