|
Catalog Number ULTRAHSUNK |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Hernia (2240)
|
Event Date 03/31/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
Product complaint # (b)(4).Adverse events will be submitted via 2210968-2021-01807.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: kitasato med j 2014; 44: 178-182.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 and ultrapro hernia plug) 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?.
|
|
Event Description
|
It was reported in a journal article with title: comparison of mesh plug and prosthesis requiring dissection of preperitoneal space for inguinal hernia repair.The aim of this retrospective study is to evaluate the author¿s 5-year period of clinical experiences of inguinal hernia.Between jan 2006 and dec 2010, adult hernioplasties were performed in 532 cases (all male patients) for 589 hernias.From 2006 to 2009, the authors mainly performed the mesh plug technique (mpt); whereas in the last year (2010), the authors mainly used the ultrapro plugs and the ultrapro hernia system repair (johnson & johnson).In 2010, hernioplasty was performed on 129 hernias in 112 cases.The type of hernias in 2010 that were treated with ultrapro plugs and the ultrapro hernia system repair (johnson & johnson) include indirect (n=68 with mean age of 66.7 ±15.0 years), direct (n=16 with mean age of 71.0 ± 9.47 years), concurrent (n=10 with mean age of 66.5 ± 8.53 years), bilateral (n=6 with mean age of 68.0 ± 10.3 years), and femoral (n=10 with mean age of 75.7 ± 7.54 years).Postoperative complications in 2010 where ultrapro plugs and the ultrapro hernia system repair were used include hematoma (n=9), ssi (n=6), seroma (n=2), recurrence (n=2), postoperative pain (n=2) and wound dehiscence (n=1).The use of heparin before surgery and prosthesis requiring dissection of preperitoneal space were risk factors for postoperative hematoma; in the case of direct hernia, the mpt was a risk factor for recurrence.
|
|
Manufacturer Narrative
|
Product complaint # pc-(b)(4).Date sent to the fda: 4/23/2021 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 and ultrapro hernia plug) 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 # pc-000845095 date sent to the fda: 4/23/2021 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.
|
|
Search Alerts/Recalls
|
|
|