Description of Event or Problem · 0
THE REPORTER STATED THAT THEY HAD TAKEN 11 VIBRANT GASTRO CAPSULE DEVICES ORALLY APPROXIMATELY FIVE TIMES PER WEEK OVER SEVERAL WEEKS AND WERE INSTRUCTED THAT THE CAPSULES WERE EXPECTED TO EXIT THE BODY WITHIN FOUR DAYS. THE REPORTER STATED THAT ONLY ONE CAPSULE EXITED THE BODY, WHILE THE REMAINING CAPSULES FAILED TO PASS AND REPORTEDLY REMAINED WITHIN THE INTESTINES FOR APPROXIMATELY THREE WEEKS. THE REPORTER INDICATED THAT ONE RETAINED CAPSULE WAS REMOVED VIA COLONOSCOPY; HOWEVER, THE REMAINING CAPSULES WERE REPORTEDLY STILL PRESENT IN THE BODY. THE REPORTER STATED THAT ABDOMINAL PAIN AND BLOATING WERE EXPERIENCED. X-RAYS WERE PERFORMED AND REPORTEDLY VISUALIZED THE RETAINED CAPSULES WITHIN THE INTESTINES. THE REPORTER DESCRIBED THE CAPSULES AS APPEARING ¿LIKE MINIATURE SUBMARINES¿ ON IMAGING AND EXPRESSED CONCERN THAT THE CAPSULES WERE STUCK IN THE BODY. PT: 1685, 2601. DEVICE: 4001, 3009. REF: MW5188451, MW5188452, MW5188453, MW5188454, MW5188455, MW5188456, MW5188457, MW5188459, MW5188460.