D
Patient 1
ON (B)(6) 2017, A PHYSICIAN'S OFFICE CONTACTED SOFREGEN TO REPORT EVENTS ASSOCIATED WITH SERI SURGICAL SCAFFOLD. THE OFFICE HAD FOUR PATIENTS WITH COMPLICATIONS REGARDING THE SERI SURGICAL SCAFFOLD. PATIENT NUMBER FOUR WAS A (B)(6) YEAR OLD FEMALE (PHYSICIAN'S OFFICE ID NUMBER: (B)(4) THAT CAME TO THE PHYSICIAN'S OFFICE ON (B)(6) 2017 FOR A REGULAR CHECK-UP POST BILATERAL BREAST REDUCTION (SURGERY DATE: (B)(6) 2017). SERI SURGICAL SCAFFOLD (LOT: P14100101A, EXPIRY: NOV-2017, PRODUCT CODE: SCF15X25AGEN) WAS USED IN THE PROCEDURE. THE PATIENT HAD NON-HEALING AREAS, ONE ON EACH SIDE. THE AREAS WERE EXCISED AND IRRIGATED. THE AREA ON THE RIGHT WAS CLOSED AND ON THE LEFT IT WAS LEFT OPEN. IN BOTH AREAS SOME OF THE SERI SURGICAL SCAFFOLD WAS NOTED, CLIPPED AND DISCARDED. CULTURES WERE DONE AND SHOWED ONLY USUAL CUTANEOUS FLORA. ON (B)(6) 2017, ANOTHER NON-HEALING AREA WAS NOTED. THERE IS NO INFORMATION ON THIS AREA AT THIS TIME. THE DEVICE WAS NOT EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.