Description of Event or Problem · 1
PRODUCT: MASTISOL LIQUID ADHESIVE. ITEM #: (B)(4). LOT # UNKNOWN. A PATIENT'S MOTHER CONTACTED FERNDALE LABORATORIES, INC TO REPORT AN ADVERSE EVENT (BLISTERING AND HIVES) ASSOCIATED WITH MASTISOL LIQUID ADHESIVE ON (B)(6) 2012. THE PATIENT HAD A C-SECTION AND MASTISOL LIQUID ADHESIVE WAS USED AT THE INCISION SITE. NO STERI-STRIPS WERE USED. SHE DEVELOPED BLISTERS AND HIVES INITIALLY AT THE INCISION SITE. ON (B)(6) 2012, THE REACTION BEGAN TO SPREAD TO HER WHOLE BODY AND SHE DECIDED TO GO TO THE EMERGENCY ROOM. THE EMERGENCY DOCTOR TREATED HER WITH A STEROID SHOT, BENADRYL AND A STEROID CREAM. SHE WAS THEN SENT HOME. THE PATIENT WAS HOPING TO FOLLOW UP WITH HER ALLERGIST AS WELL. TWO PREVIOUS REACTIONS TO BENZOIN WERE REPORTED. STERI-STRIPS WERE USED IN BOTH CASES AND BLISTERS WERE CONSISTENT WITH THE SHAPE OF THE STRIPS. THE SECOND REACTION TOOK TWO MONTHS TO CLEAR. A SKIN PATCH TEST WAS OFFERED BUT DECLINED AT THIS TIME. NO LOT NUMBER OR PACKAGING CONFIGURATION WAS PROVIDED TO FLI. ADD: SPOKE WITH REPORTER ON (B)(6) 2012, REGARDING HER DAUGHTER'S REACTION. SHE IS CURRENTLY ON STEROIDS, ANTIBIOTICS AND PAIN MEDICATION. THE REACTION IS FINALLY STARTING TO CLEAR BUT HER INCISIONS ARE BEGINNING TO SEEP DUE TO THE STEROIDS. THE REPORTER HAS PHOTOS OF THE REACTION AND WILL FORWARD TO FLI.