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Model Number UNKNOWN SURGIPRO MESH |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Exsanguination (1841); No Code Available (3191)
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Event Date 01/07/2015 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Title laparoscopic posterior mesh rectopexy for rectal prolapse is a safe procedure in older patients: a prospective follow-up study source scandinavian journal of surgery, volume 104, 2015 (227¿232).Article number: 7.Date of publication: 19 november 2014.If information is provided in the future, a supplemental report will be issued.[(b)(4].
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Event Description
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According to literature source of study performed between february 01, 2009 to june 01, 2012 in a tertiary center in (b)(6).81 eligible patients underwent laparoscopic posterior rectopexy (lpr) with application of the mesh device and secured with four to eight titanium tacks and were followed up to two years with major complications seen and one patient resulted in death (1.2%).These major complications were those that required admission more than three days, re-operation and blood transfusion.
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Search Alerts/Recalls
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