Description of Event or Problem · 1
THIS IS THE SAME EVENT AND THE SAME PATIENT REPORTED UNDER MDR ID# 2939859-2000-00107. THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT, ALSO A DEVICE MANUFACTURED BY COLLAGEN CORP. THIS SEPARATE DISTINCT NUMBER IS PROVIDED PER THE FDA'S REQUEST FOR TRACEABILITY PURPOSES. THE PATIENT HAS A FIVE YEAR HISTORY OF DERMAL AUGMENTATION WITH BOVINE COLLAGEN. THE REPORTING PHYSICIAN HAD TREATED PT ONCE OVER A YEAR AGO AND THEN PT BECAME HIS PATIENT IN 1999 RECEIVING COLLAGEN TREATMENTS IN 1999 AND ON 2 DIFFERENT DATES IN 2000. ON THE 2ND DATE IN 2000, PHYSICIAN INJECTED 1.0CC OF ONE FORMULATION OF COLLAGEN IN THE UPPER VERMILION BORDER AND NASOLABIAL FOLDS. HE ALSO INJECTED 1.0CC OF ANOTHER FORMULATION OF COLLAGEN IN THE FOREHEAD AND LIP LINES. THE PATIENT CALLED IN THE EVENING TO REPORT UPPER LIP WAS EXTREMELY SWOLLEN. HE ADVISED PT TO PUT ICE ON IT AND CALL HIM BACK IF THIS DID NOT RESOLVE. PT CALLED BACK IN 2 HOURS TO REPORT THAT THE SWELLING WAS WORSE. HE ADVISED PT TO COME TO HIS OFFICE THE NEXT MORNING. WHEN HE SAW PT HE SAID PT LOOKED LIKE PT HAD BEEN STUNG BY A BEE IN THE UPPER LIP WITH SWELLING EXTENDING UP UNDER PT'S NOSE. THERE WAS NO REDNESS OR INDURATION. THE PATIENT DENIED ITCHING. THE PHYSICIAN PRESCRIBED ORAL PREDNISONE AND THE SWELLING WAS COMPLETELY GONE BY 72 HOURS. HE DIAGNOSED HYPERSENSITIVITY TO COLLAGEN.