Description of Event or Problem · 1
THIS SERIOUS UNSOLICITED SUMMARY DEVICE CASE WAS RECEIVED FROM UNITED STAES ON (B)(6) 2013 FROM THE PHYSICIAN VIA A SALES REPRESENTATIVE. THIS CASE CONCERNS SEVERAL UNK FEMALE PATIENTS WHO DEVELOPED SMALL BOWEL OBSTRUCTIONS AND FISTULAS WHILST RECEIVING SEPRAFILM. NO PAST DRUG, MEDICAL HISTORY, CONCOMITANT MEDICATIONS OR CONCURRENT CONDITIONS WERE REPORTED. IT WAS REPORTED THAT THE PHYSICIAN HAD USED SEPRAFILM YEARS AGO (NUMBER OF SHEETS NOT PROVIDED) AT UNSPECIFIED LOCATIONS (BATCH/LOT NUMBER AND EXPIRATION DATE: NOT PROVIDED) FOR POST-OPERATIVE ADHESIONS IN SEVERAL UNKNOWN FEMALE PATIENTS WHO DEVELOPED SMALL BOWEL OBSTRUCTIONS AND FISTULAS. CORRECTIVE TREATMENT: NOT REPORTED. OUTCOME: UNK A PHARMACEUTICAL TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: 28952. NO LOT NUMBER WAS PROVIDED BY THE REPORTER; GENZYME BIOSURGERY QUALITY ASSURANCE (QA) WAS UNABLE TO PERFORM A SPECIFIC LOT HISTORY REVIEW AND INVESTIGATION FOR THIS EVENT. IF A LOT NUMBER IS REPORTED AT A LATER DATE, THIS PRODUCT EVENT WILL BE REOPENED AND AN INVESTIGATION WILL BE PERFORMED BY GENZYME QA. SERIOUSNESS CRITERIA: THE EVENTS WERE ASSESSED AS SERIOUS PER THE NEW IME LIST. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(4) 2013: PTC RESULTS WERE UPDATED.