Boston scientific corporation became aware of the following events through the article "antimicrobial prophylaxis in patients undergoing endoscopic mucosal resection for 10- to 20-mm colorectal polyps" written by linfu zheng, et.Al.The study aimed to investigate the clinical impact of using prophylactic antibiotics during the perioperative period of endoscopic mucosal resection (emr) for colorectal polyps.According to the literature, a total of 246 patients who met the inclusion criteria underwent endoscopic mucosal resection at the 900th hospital of pla for emr from january 2016 to november 2019.It was reported that 22 patients had mild abdominal pain that was relieved by a spasmolytic.In addition, 21 cases of delayed bleeding were observed after the emr procedure.The bleeding was controlled with clips, and there was no subsequent bleeding.Note: no further information has been obtained despite good faith efforts.
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Block b3: it was reported that the procedures were between (b)(6) 2016 and (b)(6) 2019.Block d4, h,4: the suspect device upn and lot number are not reported; therefore, the manufacture and expiration dates are unknown.Block g3: literature source journal article: zheng l, jiang l, li d, chen l, jiang c, xie l, zhou l, huang j, liu m, wang w."antimicrobial prophylaxis in patients undergoing endoscopic mucosal resection for 10- to 20-mm colorectal polyps: a randomized prospective study." medicine 2022;101:50(e31440).Block h6: imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e0506 captures the reportable event of hemorrhage, major.Imdrf impact code f2202 captures the reportable event of endoscopic procedure.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.
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