NEOSPORIN SCAR SOLUTION SILICONE SCAR SHEETS

Description of Event or Problem

THIS SPONTANEOUS REPORT CONCERNS A 44 YEAR OLD FEMALE PATIENT REPORTING FOR HERSELF FROM THE UNITED STATES: 011869181A. INITIAL INFORMATION WAS PROCESSED WILH ADDITIONAL INFORMATION RECEIVED ON 29-MAR-2012. THE PATIENT'S WEIGHT WAS 100 POUNDS. THE PATIENT'S HEIGHT WAS 62 INCHES. THE PATIENT'S MEDICAL HISTORY AND CONCURRENT CONDILLONS INCLUDED: SOME CHEMICAL ALLERGIES, "BUNCH OF FOOD ALLERGIES BUT NOT SURE WHICH ONES", LATEX ALLERGY, AND SEASONAL ALLERGIES. THE PATIENT WAS TREATED WITH NEOSPORIN SCAR SOLUTION SILICONE SCAR SHEETS (SHEETS, TOPICAL, LOT 40261, EXPIRY OCT-2006) (EXPIRED PRODUCT) ONE, ONCE INITIATED ON (b)(6) 2012 AND WITHDRAWN 2012 TO REDUCE BLOTCHES ON FACE (OFF LABEL USE). CONCOMITANT MEDICATIONS ALL WITH UNSPECIFIED FORMULATION, ROUTE AND DOSE INCLUDED MULTIVITAMINS ONCE DAILY FOR NUTRITION SUPPLEMENT, MAGNESIUM ONCE DAILY FOR NUTRITION SUPPLEMENT, CALCIUM ONCE DAILY FOR NUTRITION SUPPLEMENT, SPIRULINA (SPIRULINA SPP.) ONCE DAILY FOR NUTRITION SUPPLEMENT, OMEGA 3/69 (FISH OIL) FOR NUTRITION SUPPLEMENT, COQLO (UBIDECARENONE) AS NEEDED FOR NUTRITION SUPPLEMENT, BEE POLLEN AS NEEDED FOR NUTRITION SUPPLEMENT, GINKGO (GINKGO BILOBA) AS NEEDED FOR NUTRITION SUPPLEMENT, AND VITAMIN D (COLECALCIFEROL) ONCE DAILY FOR NUTRITION SUPPLEMENT. ON (b)(6)2012 AFTER SLEEPING WITH THE PRODUCT ON, THE PATIENT EXPERIENCED UPON AWAKENING BLURRY EYES, EYE PRESSURE, SWOLLEN RED EYES AND BUMPS ON EYES AND FOREHEAD (BUMPS ON SKIN). SHE STATED THAT SHE ALSO HAD SOME REDNESS ON HER FACE, AND IT FELT LIKE THERE WAS SOMETHING UNDERNEATH HER SKIN. AS TREATMENT, THE PATIENT WASHED HER FACE WITH SOAP AND WATER AND ADMINISTERED ARTIFICIAL TEARS "TO TRY AND DRAIN EYES TREATMENT WITH NEOSPORIN SCAR SOLUTION SILICONE SCAR SHEETS WAS WITHDRAWN ON (b)(6) 2012. AT THE TIME OF REPORTING, THE PATIENT HAD NOT RECOVERED FROM BLURRY EYES, SWOLLEN RED EYES, EYE PRESSURE AND FACIAL REDNESS, FELT LIKE THERE WAS SOMETHING UNDERNEATH HER SKIN AND WAS RECOVERING FROM BUMPS ON EYES AND FOREHEAD. THIS REPORT WAS NOT SERIOUS AND NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 26-APR-2012. THE PATIENT NOTED AN OFFICE VISIT TO A ''REGULAR'' DOCTOR AND ANOTHER OFFICE VISIT TO AN OPHTHALMOLOGIST. ON AN UNSPECIFIED DATE, THE PATIENT VISITED A DOCTOR AND, ACCORDING TO THE PATIENT, 11WOULD NOT TEST BECAUSE HER VISION WAS BLURRY." THE PATIENT "NEEDED TO GET TESLED FOR CLOSE-UP" AND "WOULD HAVE TO COME BACK TO BE RE-TESTED WHEN HER EYES WERE BETTER." A FOLLOW-UP WITH AN EYE SPECIALIST WAS REQUIRED. ON AN UNSPECIFIED DATE, THE PATIENT HAD RECOVERED FROM SWOLLEN EYES. THIS REPORT WAS NOT SERIOUS AND NOT REPORTABLE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 14-MAY-2012. AN ADDITIONAL TELEPHONE NUMBER OF THE PATIENT WAS ADDED. THIS REPORT WAS NOT SERIOUS AND NOT REPORTABLE. ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON 15-MAY-2012 IN THE FORM OF A LETTER AND DISCHARGE INSTRUCTIONS FROM AN EMERGENT CARE FACILITY. ONSET DATE OF THE EVENTS WERE UPDATED TO (b)(6) 2012. ADVERSE EVENTS WERE UPDATED AS FOLLOWS: ON (b)(6 )2012 THE PATIENT EXPERIENCED HEAD PAIN, PAIN IN HER JAW AND ENTIRE RIGHT SIDE OF HER FACE AND REDNESS FROM THE PAIN. SHE APPLIED THE ADHESIVE (NEOSPORIN SCAR SOLUTION SILICONE SCAR SHEETS) AS SHE NORMALLY WOULD ON HER FOREHEAD AND AROUND THE AREA OF HER NOSE AS ONE WOULD IF IT WERE A BAND-AID TO TREAT THE REDNESS FROM THE PAIN. THE PATIENT TOOK A SHORT NAP LATER IN THE DAY AND THE ADHESIVE SLID OFF AND WAS IN THE CORNER OF HER EYE. THE ADHESIVE DID NOT HOLD OR BOND WITH HER SKIN, THE ADHESIVE CORNER WAS AT THE TIP OF HER EYE AND THE PRODUCT DRIPPED INTO HER EYE WELL, POSSIBLY FROM PERSPIRATION (POOR ADHESION). SHE IMMEDIATELY KNEW SOMETHING WAS WRONG AS SHE COULD NOT OPEN HER EYES (COULDN'T OPEN EYELIDS). HER EYES WERE BADLY SWOLLEN, RED, BLOODSHOT, AND WATERY AND HER VISION WAS BLURRED. THE INCIDENT REPORTEDLY RUINED HER EYESIGHT AND DESTROYED HER ABILITY TO SEE (EYESIGHT DECREASED). THINGS APPEARED CLOUDED AND BLURRY. SHE EXPERIENCED EYE STRAIN, LIGHT SENSITIVITY AND HAD DIFFICULTY SEEING THINGS CLOSE UP. ON (b)(6) 2012 THE PATIENT WAS SEEN AT A COMMUNITY EMERGENCY CLINIC AND WAS DIAGNOSED WITH HERPES ZOSTER (SHINGLES}. TREATMENT FOR THE HERPES ZOSTER INCLUDED PREDNISONE (TABLET, ORAL) 50 MG ONCE DAILY FOR 7 DAYS, KEEPING THE LESIONS CLEAN AND DRY AND COVERING WITH BACITRACIN, WARM CLEAN COMPRESSES TO RIGHT EYE AND TYLENOL (ACETAMINOPHEN) OR IBUPROFEN FOR PAIN. THE PATIENT OUTCOME FOR THE EVENTS DIFFICULTY SEEING CLOSE UP, EYESIGHT DECREASED, LIGHT SENSILIVITY AND BLURRY EYES WAS NOT RECOVERED. THE PATIENT OUTCOME FOR THE EVENTS GOT PRODUCT IN EYE, POOR ADHESION, EXPIRED PRODUCT USED, OFF LABEL USE AND SWOLLEN EYE WAS RECOVERED/RESOLVED. THE PATIENT OUTCOME FOR THE EVENTS EYE STRAIN, FACIAL REDNESS, BUMPS ON SKIN, EYE PRESSURE AND FEELS LIKE SOMETHING UNDERNEATH SKIN WERE NOT ADDRESSED BY THE PATIENT AND WERE NOT CHANGED FROM THE PREVIOUS REPORT. CASE UPGRADED TO SERIOUS BASED ON ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON 20-MAR-2013. ON AN UNSPECIFIED DATE THE PRODUCT DAMAGED THE PATIENT'S EYE SIGHT (DECREASE OF EYE SIGHT}. THE PATIENT ADDED IT HAD BEEN ALMOST A YEAR SINCE SHE FILED HER CLAIM. THE PATIENT OUTCOME FOR DECREASE OF EYE SIGHT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED FROM JOHNSON AND JOHNSON LAW ON 26-MAR-2013 IN THE FORM OF A LETTER SENT TO THE PATIENT REGARDING HER CLAIM. NO NEW MEDICAL INFORMATION WAS ADDED TO THE CASE DUE TO THIS CONTACT. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT} AND REPORTABLE (SERIOUS INJURY). ADDITIONAL INFORMATION RECEIVED FROM PATIENT ON 27-MAR-2013 AND COMPLAINT VIGILANCE ON 01-APR-2013 (COMBINED). THE PATIENT OUTCOME FOR THE EVENT WATERY EYES WAS UPDATED TO RECOVERED (PREVIOUSLY NOT PROVIDED} EXPIRED PRODUCT WAS NOT RECOVERED (PREVIOUSLY REPORTED AS RECOVERED) AND SWOLLEN RED EYE WAS RECOVERING (PREVIOUSLY REPORTED AS RECOVERED}. AS PER COMPLAINT VIGILANCE, THE LOT NUMBER PROVIDED WAS INVALID. BASED ON THE EXPIRATION DATE REPORTED (LL-OCT-2006), THE PRODUCT EXPIRED OVER 5 YEARS AGO. IN ADDITION, THE PRODUCT HAS BEEN DISCONTINUED. RESULTS OF LHE INVESTIGATION WERE UNDETERMINED (INVESTIGATION CLOSED ON 18-JUL-2012). THE INVESTIGATION DID NOT IDENTIFY THE ROOT CAUSE. THIS REPORT IS ASSOCIATED WITH COMPLAINT VIGILANCE REFERENCE NUMBER (b)(4).

Additional Manufacturer Narrative

RESULTS OF THE INVESTIGATION WERE UNDETERMINED (INVESTIGATION CLOSED ON 18- COMPANIES,INC JUL-2012). THE INVESTIGATION DID NOT IDENTIFY THE ROOT CAUSE. SEE SCANNED PAGES.