Product complaint #: (b)(4).Date sent to the fda: 3/1/2021.(b)(4) - device not returned.This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: journal of medical science in central south china; vol.39 no.4, jul 2011; doi: 10.15972/j.Cnki.43-1509/r.2011.04.025.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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It was reported in a journal article with title: application of inguinal hernia repair with ultrapro hernia system under local anesthesia in elderly patients.The objective of this retrospective study was to summarize the clinical experience of tension ¿ free repair for inguinal hernia by ultrapro hernia system (uhs) under local anesthesia.From may 2008 to may 2009, 38 elderly patients (male=35, female=3; age=over 65 years old; body mass index= less than 25 kg/m^2) underwent inguinal hernia repair with uhs under local anesthesia.During the procedure, the upper patch of the uhs (ethicon) was folded in half and clamped with sponge forceps.The lower patch was folded into an umbrella shape with the sponge forceps as the center and placed into the preperitoneal space through the hernia ring.The lower patch was released, the upper patch was tracted, the lower patch was expanded flat in the preperitoneal space with fingers, the patient was instructed to cough to flatten the patch from the inside to the abdominal wall by abdominal pressure, and the hernial sac was checked for bulging.Reported complications included pain in the area of the incision was mild (n=38) in which only 3 patients were given analgesics; acute urinary retention (n=2) which the patients urinated spontaneously one day after catheter insertions; scrotal effusion (n=1) which was cured by puncturing and aspiration.In conclusion, uhs herniorraphy under local anesthesia is a simple, safe, and effective treatment for the elderly patients, specially suit for aged patients with weak posterior wall of inguinal duct, large defect and general complications.
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