D
Patient 1
HOLD - AB 05/09/2014 IT WAS REPORTED THAT A (B)(6) MALE SUFFERED SKIN MACERATION UNDER THE CASTING MATERIALS USED AT A USER FACILITY. THE PATIENT'S FATHER STATED THAT HE ALLOWED HIS SON TO SWIM IN A POOL AND BATHE, BUT NEVER ALLOWED HIM TO SWIM OR PLAY IN ANY LAKES, RIVERS OR OCEANS. THE FATHER REPORTED THAT THERE WAS SIGNIFICANT EXCORIATION OF THE SKIN WITH A RASH INVOLVING THE ENTIRE AREA UNDERNEATH THE CAST WITH SOME PEELING OF THE SKIN THAT WAS PROMINENT. PATIENT'S PARENTS WERE ADVISED TO PROCEED WITH LOCAL WOUND CARE AND FOLLOW-UP TREATMENT. PARENTS SCHEDULED FOLLOWED-UP TREATMENT WITH FAMILY DOCTOR (3 VISITS) FOR WOUND CARE. THE DOCTOR GAVE THE PATIENT A SHOT AS A PRECAUTIONARY MEASURE FOR INFECTION AND ADVISED THE PARENTS TO APPLY TOPICAL ANTIBIOTIC CREAM AND DRESSING TO THEIR SON'S ARM TWICE A DAY UNTIL THE SKIN RECOVERED. THE PATIENTS FATHER STATED THAT THIS WENT ON FOR APPROXIMATELY 3 MONTHS, BUT PATIENT IS DOING WELL NOW. THE INITIAL REPORT WAS SENT TO THE COMPANY ON (B)(4) 2014 BY THE USER FACILITY AS THE BILL FOR SERVICES WENT INTO COLLECTIONS. NO SAMPLE AND NO LOT NUMBER WERE PROVIDED. THE FACILITY CONTACT THAT REPORTED THE COMPLAINT TO COMPANY REPRESENTATIVE DID NOT RESPOND TO ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ALLEGED INCIDENT. A CERTIFIED LETTER HAS BEEN SENT.