MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Catalog Number ULTRAPLUGUNK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Pain (1994); Seroma (2069); Hernia (2240)

Event Date 03/31/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).  adverse events will be submitted via 2210968-2021-01808.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? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

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 # (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 # (b)(4).Date sent to the fda: 4/23/2021.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.

• Brand Name: ULTRAPRO HERNIA PLUG UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08876
• MDR Report Key: 11382631
• MDR Text Key: 233693688
• Report Number: 2210968-2021-01807
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAPLUGUNK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention