REFERENCE RECORD (B)(4). CATALOG NUMBER IS THE INTERNATIONAL LIST NUMBER WHICH IS SIMILAR TO US LIST NUMBER OF 062918-001. THE DEVICE INVOLVED IN THE EVENT WAS NOT RETURNED AND WAS DISCARDED; THEREFORE, A RETURN SAMPLE EVALUATION IS UNABLE TO BE PERFORMED. PERITONITIS IS A KNOWN COMPLICATION OF A PEG TUBE/ J-TUBE PLACEMENT. PER INSTRUCTIONS FOR USE (IFU), THE PEG TUBE SHOULD BE PULLED UNTIL ELASTIC RESISTANCE IS FELT, KEPT UNDER TENSION, FIXATION PLATE SHOULD BE SECURED 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. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
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Patient 1
ON (B)(6) 2020, A PATIENT IN (B)(6) UNDERWENT A PROCEDURE FOR THE PLACEMENT OF PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE WITH JEJUNAL (PEG-J) TUBE. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED ABDOMINAL PAIN AND ELEVATED WBC (14.39). THE PATIENT WAS PROPHYLACTICALLY TREATED WITH INTRAVENOUS AUGMENTIN 1200MG THREE TIMES A DAY. ON (B)(6) 2020 THE PATIENT WAS DIAGNOSED WITH ACUTE PERITONITIS AND ELEVATED CRP (44.9). THE PEG/PEG-J TUBES WERE REMOVED AND DUOPA THERAPY WAS SUSPENDED AND INITIATED ORAL THERAPY. REPEAT BLOOD TEST COMPLETED ON (B)(6) 2020 SHOWED INCREASED CRP (281.4) LEVEL. ON (B)(6) 2020 THE PATIENT EXPERIENCED REPETITIVE VOMITING AND SWELLING IN THE ABDOMEN. X-RAY CONFIRMED GASTROPARESIS AND BLOOD TEST RESULT SHOWED CONTINUED WBC (14.11) ELEVATION. ON AN UNKNOWN DATE THE PATIENT BEGAN TWO INTRAVENOUS ANTIBIOTIC THERAPY; CEFEPIME 2000MG THREE TIMES A DAY FROM (B)(6) 2020 TO (B)(6) 2020 AND AMANTADINE SULFATE 200MG TWO TIMES A DAY. ON (B)(6) 2020, REPEAT BLOOD TEST RESULTED IN WBC (5.53) WITHIN NORMAL LIMITS AND DECREASED CRP (7.2). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2020 AND REFERRED TO A REHABILITATION CENTER. DUOPA THERAPY HAS BEEN DISCONTINUED AND THE PATIENT CONTINUES TO TAKE ORAL MEDICATIONS.