Description of Event or Problem · 1
PRODUCT: MASTISOL LIQUID ADHESIVE. ITEM #: 0523-XX. LOT # UNK. A PT CONTACTED FERNDALE LABORATORIES, INC VIA EMAIL ON (B)(6) 2011, TO REPORT AN ADVERSE EVENT (ITCHING, REDNESS AND SWELLING) ASSOCIATED WITH MASTISOL LIQUID ADHESIVE. NO LOT NUMBER OR PACKAGING CONFIGURATION WAS PROVIDED TO FLT. THE FEMALE PT HAD NECK SURGERY IN (B)(6) 2011, THROUGH THE FRONT OF HER NECK. MASTISOL LIQUID ADHESIVE WAS USED TO SECURE GAUZE OVER THE INCISION SITES. SHE BEGAN EXPERIENCING ITCHING, REDNESS AND SWELLING WITHIN 24 HOURS. DIFFICULTY SWALLOWING DUE TO THE SWELLING WAS NOTED. THE PT WENT TO THE ER TWICE DUE TO THE REACTION. SHE WAS GIVEN BENADRYL PRODUCT THE FIRST TIME AND NO CHANGE WAS NOTED. THE SECOND TIME SHE WAS GIVEN STEROID SHOTS AND 10 DAYS OF PREDNISONE. THE REACTION BEGAN TO CLEAR QUITE QUICKLY ONCE SHE WAS ON THE STEROIDS. THE PT'S PHYSICIANS (SURGEON AND ALLERGIST) WERE UNSURE WHAT EXACTLY CAUSED THE REACTION. A PATCH TEST WAS COMPLETED BY HER ALLERGIST WITH MASTISOL LAST WEEK AND SHE EXPERIENCED A SIMILAR REACTION. DUE TO THE REACTION, SHE IS BACK ON PREDNISONE AND WAS INSTRUCTED TO APPLY A STEROID CREAM TO THE AREA PATCH-TESTED. SHE HAS REQUESTED A SKIN PATCH TEST OF THE COMPONENTS TO DETERMINE WHICH INGREDIENT(S) SHE IS ALLERGIC TO. THE PATCH TEST WAS SENT TO HER ALLERGIST ON (B)(6) 2011. THE PT REPORTED SHE HAS PHOTOS OF THE REACTION AND WOULD FORWARD THEM VIA E-MAIL. A F/U E-MAIL WAS SENT TO THE PT ON (B)(6) 2011, REGARDING THE PHOTOS. TO DATE NO PHOTOS HAVE BEEN RECEIVED ((B)(4) 2011). THE PHOTOS WILL BE FORWARDED TO FLI'S CONSULTING PHYSICIAN UPON RECEIPT. KNOW ALLERGY TO SURGICAL TAPE WAS REPORTED. (B)(4).