Description of Event or Problem · 1
REPORTER CONTACTED THE MFR IN 2001 ADVISING THAT A DR WEARING THE MFR'S POLYETHYLENE GOWN DEVELOPED A RASH AND HIVES. THE DR IS ALLERGIC TO LATEX. THE DR TOOK A MEDICATION TO CLEAN UP THE ALLERGIC REACTION. IT WAS SUSPECTED THAT THE GOWN CAUSED THE REACTION; HOWEVER, THE GOWN IS MADE 100% OF POLYETHYLENE WITH NO LATEX. SUMMARY OF PRODUCT COMPLAINT: HOSP NOTIFIED MFR THAT A DR HAD WORN MFR'S 294 GOWN FOR A PERIOD OF APPROX 1-1/2 HOURS FOR A DISASTER TRAINING DRILL IN 2001. UPON TAKING THE GOWN OFF, THE DR IMMEDIATELY DEVELOPED A RASH AND HIVES ON THE DR'S FACE AND ARMS, WHICH DR SAYS WERE ONE BIG HIVE. DR WAS ABLE TO TAKE SEVERAL DIFFERENT MEDICATIONS TO CLEAR UP THE HIVES, AND THAT TOOK APPROX 1 HOUR TO CLEAR IT UP. A MEETING WAS HELD THAT AFTERNOON AND MFR HAD A CONFERENCE CALL WITH DR. SEVERAL QUESTIONS WERE ASKED OF THE DR, AND THE DR'S ANSWERS ARE LISTED BESIDE THE QUESTIONS. WHERE WAS DISASTER TRAINING HELD? INSIDE AIR CONDITIONED BUILDING. WHAT IS THE DR ALLERGIC TO? DR IS ACUTELY ALLERGIC TO LATEX. HAD DR WORN THIS GOWN BEFORE? NO. DID ANYONE ELSE WEAR THE MFR'S 294 GOWN? YES, BUT DR SAID A NURSE THERE DEVELOPED A MILD REACTION, AND DR THOUGHT DR MIGHT HAVE BRUSHED THE NURSE'S ARM WHILE WEARING THE 294 GOWN. WHAT KIND OF CLOTHING DID DR HAVE UNDER GOWN? T SHIRT. WERE ANY LIQUIDS INVOLVED? NO. DOES DR HAVE GOWN DR WAS WEARING WHEN REACTION OCCURRED? NO, BUT DR WILL SEND A PARTIAL BOX BACK TO THE MFR TO TEST. WHO IS DISTRIBUTOR? KREISERS OR MIDLAND MED IN LINCOLN.