REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062912. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND REMAINED IMPLANTED IN THE PATIENT; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. ? A PNEUMOPERITONEUM IS A KNOWN COMPLICATION OF A PEG TUBE PLACEMENT. PER THE INSTRUCTIONS FOR USE (IFU): TO SECURE THE PEG TUBE, THE PEG TUBE SHOULD BE PULLED UNTIL ELASTIC RESISTANCE IS FELT, KEEP UNDER TENSION, SECURE FIXATION PLATE INTO POSITION USING THE CLIP, AND REMAIN UNDER MODERATE TENSION FOR 24-72 HOURS TO PROMOTE GOOD ADHERENCE TO THE STOMACH WALL TO THE INNER ABDOMINAL WALL. (B)(4). IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
D
Patient 1
ON (B)(6) 2020, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE. THE PATIENT WAS HOSPITALIZED FOR DUOPA THERAPY TITRATION. ON (B)(6) 2020 THE PATIENT EXPERIENCED ABDOMINAL PAIN. CT SCAN WAS COMPLETED ON THE SAME DAY AND CONFIRMED THE PRESENCE OF ACCUMULATED AIR IN THE ABDOMEN. ON (B)(6) 2020 THE ADVERSE EVENT OF ABDOMINAL PAIN RESOLVED. ACCUMULATION OF AIR IN THE ABDOMEN IS ONGOING AND WILL CONTINUE TO BE MONITORED IN THE HOSPITAL. ON (B)(6) 2020, IT WAS REPORTED THAT THE ADVERSE EVENT OF PNEUMOPERITONEUM HAS RESOLVED AND DUOPA THERAPY CONTINUES.