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Catalog Number ULTRAHSUNK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Urinary Retention (2119); Discomfort (2330); Swelling/ Edema (4577)
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Event Date 07/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product complaint # (b)(4).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 the third military medical university, 2017, 39 (21); doi: 10.16010/j.1000-5404.201705088.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products (ultrapro hernia system) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved?.
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Event Description
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It was reported in a journal article with title: tumescent local anesthetic technique for preperitoneal tension-free hernioplasty: a retrospective study.This study aimed to evaluate the efficacy and safety of tumescent local anesthetic (tla) technique for preperitoneal tension-free hernia repair.From jan2012 to mar2016, 184 patients with inguinal hernia underwent preperitoneal tension-free hernioplasty.Of these 184 cases, 98 cases were given tumescent local anesthesia (the tla group; n=70 male and n=28 female; age of 56±13 years), and conventional local anesthesia was administered during the operation in 86 cases (the la group; n=60 male and n=26 female; age of 58±12 years).Both groups of patients were treated with the ultrapro hernia system (uhs) hernia repair materials produced by johnson & johnson, and no sedative or analgesic drugs were used in either group before surgery.In both groups, complications included use of analgesics 1 day after the operation (n=30), incidence of persistent pain (n=7), urinary retention (n=1), discomfort in the operation area (n=2) which gradually disappeared after the patient got out of bed and carried out activities.These events got better without special treatment.Postoperative analgesia from tumescent local anesthesia lasts longer, resulting in fewer cases that used analgesics at 1 day after surgery, which implies that tumescent local anesthesia has a better postoperative analgesia effect tla in inguinal hernia repair can reduce the operative time and usage of lidocaine, and achieve sound safety and good intraoperative analgesic effect.What's more, it has superior in analgesic duration to conventional anesthesia.
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Manufacturer Narrative
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Product complaint # (b)(4).Date sent to the fda: 4/2/2021.The following information was requested, but unavailable: were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the ethicon products (ultrapro hernia system) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Product complaint # (b)(4).Corrected information: d3, g1.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.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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