D
Patient 1
THIS WAS A SPONTANEOUS REPORT FROM A PT AND CONCERNED HER (B)(6) MALE SON FROM THE UNITED STATES: (B)(6). THE PT'S WEIGHT WAS (B)(6) AND HEIGHT WAS (B)(6). THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED: CEREBRAL PALSY AND SINUS PROBLEMS. OTHER MEDICAL HISTORY INCLUDED THE PT HAD NO KNOWN DRUG ALLERGIES. CONCOMITANT MEDICATIONS INCLUDED MONTELUKAST FOR SINUS DISORDER, TIZANIDINE HYDROCHLORIDE FOR MUSCLE CONTRACTIONS, LORATADINE FOR SINUS DISORDER, AND IBUPROFEN FOR PAIN, THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (TOPICAL) ONE PATCH AS NEEDED INITIATED ON AN UNSPECIFIED DATE FOR MUSCLE ACHES. ON (B)(6) 2012, THE PT EXPERIENCED A HEADACHE, WATER BLISTERS AND REDNESS AT THE APPLICATION SITE. ACTION TAKEN WITH PRECISE PAIN RELIEVING HEAT PATCH WAS WITHDRAWN. AT THE TIME OF THIS REPORT, THE PT HAD NOT RECOVERED FROM WATER BLISTERS, APPLICATION SITE RED AND HEADACHE. THIS REPORT WAS NOT SERIOUS AND NOT REPORTABLE. CASE UPGRADED TO SERIOUS BASED ON ADD'L INFO RECEIVED FROM THE PT'S MOTHER ON SEPTEMBER 18, 2012. A COMPLETED AND SIGNED MEDICAL AUTHORIZATION LETTER CONTAINING CONTACT INFO FOR THE PRESCRIBING PHYSICIAN WAS RECEIVED. VERSION 1 WAS CREATED TO ENTER THE PHYSICIAN'S ADDRESS THE SCHEDULE DUE DILIGENCE. PT DEMOGRAPHICS WERE UPDATED. THE PT'S MEDICAL HISTORY AND CONCURRENT CONDITIONS INCLUDED CEREBRAL PALSY THAT WAS A BIRTH RELATED INJURY, MUSCLE PAIN, "NEVER HAPPENED BEFORE" (NO REACTION UPON PREVIOUS EXPOSURE TO DRUG" AND NON SMOKER. THE PT DENIED ANY HISTORY OF ALCOHOL USE AND DRUG ABUSE. THE PT WAS TREATED WITH PRECISE PAIN RELIEVING HEAT PATCH (PATCH, TOPICAL, LOT 100802 (PREVIOUSLY BPC010) ONE PATCH APPLIED TO RIGHT KNEE FOR 5.5 TO 6 HOURS INITIATED ON (B)(6) 2012. CONCOMITANT MEDICATIONS INCLUDED ZANAFLEX (TIZANIDINE HYDROCHLORIDE) EVERY NIGHT SINCE (B)(6) 2011 FOR MUSCLE SPASM AND LORATADINE EVERY NIGHT SINCE (B)(6) 2008 FOR SINUS CONGESTION. ON (B)(6) 2012 (PREVIOUSLY (B)(6) 2012) WHEN THE PATCH WAS REMOVED, THERE WAS REDNESS (APPLICATION SITE REDNESS). AFTER THE PT RETURNED HOME FROM SCHOOL, HIS KNEE WAS EXTREMELY RED WITH BLISTERS. HE ALSO COMPLAINED OF A HEADACHE. THE REPORTED STATED, AFTER CONSULTING WITH THE PT'S PHYSICIAN BY TELEPHONE, NEOSPORIN (BACITRACIN, ZINC, NEOMYCIN, POLYMYXIN B SULFATE) (UNSPECIFIED FORMULATION, ROUTE, DOSE AND FREQUENCY) AND GAUZE WAS ADMINISTERED FOR SEVERAL DAYS. THE REPORTER STATED, THE PT WAS RECOVERING BUT HAS SCARRING ON HIS KNEE. AT THE TIME OF THE REPORT, PRODUCT USE WAS WITHDRAWN AND THE OUTCOME OF THE EVENTS WAS RECOVERING. THIS REPORT WAS SERIOUS (MEDICALLY SIGNIFICANT) AND REPORTABLE (SERIOUS INJURY).