Description of Event or Problem · 1
THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID #2939859-1999-00007 AND 2939859-1999-00008. THIS IS THE FIRST MDR SUBMITTED FOR THE FIRST SUSPECT PRODUCT. A PHYSICIAN REPORTED A PT WHO WAS ORIGINALLY SKIN TESTED ON 21 OCTOBER 1998 WITH NEGATIVE RESULTS. ON 23 NOVEMBER 1998, THE PT WAS TREATED WITH THREE FORMULATIONS OF PRODUCT IN THE UPPER AND LOWER VERMILION BORDERS, NASOLABIAL FOLDS, PERIORBITAL FINE LINES, AND TRANSVERSE FOREHEAD LINES. THE PHYSICIAN NOTED A LITTLE INITIAL REDNESS AT THE NOSOLABIAL FOLDS, WHICH HE ATTRIBUTED TO THE TREATMENT PROCEDURE AND THE SENSITIVITY OF THE PT'S SKIN. THE PT STATED THAT THE REDNESS WAS RESOLVING SATISFACTORILY, BUT ON OR ABOUT 30 NOVEMBER 1998, THE REDNESS INCREASED IN THE NASOLABIAL FOLDS AND APPEARED AT THE VERMILION BORDERS, ALONG WITH SIGNIFICANT SWELLING IN THESE AREAS. THE PHYSICIAN DID NOT ATTRIBUTE THE SYMPTOMS TO HYPERSENSITIVITY BECAUSE THE PERIORBITAL AND FOREHEAD AREAS WERE ASYMPTOMATIC. ON OR ABOUT 12 DECEMBER 1998, THE PHYSICIAN PRESCRIBED A MEDROL DOS-PAK. ON OR ABOUT 12 DECEMBER 1998, THE SYMPTOMS OF REDNESS AND SWELLING BEGAN AT THE FOREHEAD AND PERIORBITAL TREATMENT SITES. BY ABOUT 12 DECEMBER 1998, THE SWELLING AT THE VERMILION BORDER HAD LESSENED CONSIDERABLY; HOWEVER, ALL SITES WERE CONTINUOUSLY RED AND ITCHY. SUBSEQUENTLY, THE PT STATED THAT ITCHING INCREASED AFTER BEGINNING THE MEDROL. THE PT HAD ALSO BEEN USING A TOPICAL HYDROCORTISONE CREAM WITHOUT MUCH RELIEF (START DATE NOT RECALLED). THE PT NOTED THAT THE SYMPTOMS WORSENED AFTER THE CONSUMPTION OF RED WINE. WITH ONSET OF SYMPTOMS IN THE PERIORBITAL AND FOREHEAD AREAS, THE PHYSICIAN DIAGNOSED A HYPERSENSITIVITY. CONTINUED FROM C7. EXPIRATION DATES: #1 ZYPLAST COLLAGEN IMPLANT: 07/31/2001, 02/28/2001.