Description of Event or Problem · 1
THIS SERIOUS UNSOLICITED DEVICE CASE WAS RECEIVED FROM UNITED STATES ON (B)(6) 2013 FROM A PHYSICIAN. THIS CASE CONCERNS A PATIENT (DEMOGRAPHICS UNSPECIFIED) WHO DEVELOPED BACTERIA ON SEPRAFILM (DEVICE RELATED INFECTION) AFTER PLACEMENT OF SEPRAFILM. NO RELEVANT MEDICAL HISTORY, PAST DRUGS, OTHER CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT UNSPECIFIED SURGICAL PROCEDURE WITH PLACEMENT OF SEPRAFILM (NUMBER OF SHEETS NOT PROVIDED) AT AN UNSPECIFIED ANATOMICAL LOCATION (BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) FOR POST-OPERATIVE ADHESIONS. THE PHYSICIAN MENTIONED THAT THE PATIENT'S BODY TREATED SEPRAFILM AS A FOREIGN SUBSTANCE AND DEVELOPED BACTERIA ON IT (DEVICE RELATED INFECTION). IT WAS REPORTED THAT IT WAS NOT SURE BUT THERE MIGHT HAVE BEEN SEPSIS INVOLVED. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK. A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: 28820. NO PRODUCT LOT NUMBER WAS PROVIDED BY THE REPORTER; THEREFORE, GENZYME BIOSURGERY QUALITY ASSURANCE IS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW/INVESTIGATION IN RESPONSE TO THIS EVENT. ALL SEPRAFILM LOTS MANUFACTURED BY GENZYME ARE RELEASED FOR SHIPMENT BY QUALITY ASSURANCE ONLY AFTER SUCCESSFUL COMPLETION OF QUALITY CONTROL CERTIFICATE OF ANALYSIS TESTING AND REVIEW OF ALL DEVICE HISTORY RECORDS AND ASSOCIATED MANUFACTURING PROCESS DOCUMENTATION. THIS LOT RELEASE PROCEDURE PROVIDES ASSURANCE THAT ALL PRODUCT LOTS ARE MANUFACTURED UNDER SPECIFIED PROCESS PARAMETERS AND PASS FINAL PRODUCT SPECIFICATIONS. SERIOUSNESS CRITERIA: THE EVENT WAS ASSESSED AS SERIOUS PER THE NEW IME LIST. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2013. PTC INVESTIGATION REPORT WAS ADDED.