The device(s) has not been received by the manufacturer for evaluation.A lot history review (lhr) review is not possible; as no manufacturing lot number(s) has been provided.Per 21 cfr part 803.56 not enough information has been provided about each identified patient and/or device mentioned.Therefore, one emdr is being submitted for multiple reportable events, identified in the literature search.
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It was reported that 5 cases (2.43%) of thromboembolism were confirmed as postoperative complications after groshong picc insertion.This information was obtained from the following article.Akimori miki et, al." utility and safety of peripherally inserted central venous catheter (picc) for patients in digestive surgery department ¿ analysis and examination of 217 cases in a single facility - " journal of japan surgical association, october 20, 2018, vol.79, page 460.
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