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

Catalog Number ULTRAHSUNK

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

Patient Problems Airway Obstruction (1699); Pain (1994); Seroma (2069); Urinary Retention (2119); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/02/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).  adverse events will be submitted via mw# 2210968-2020-03129, mw# 2210968-2020-03130, and mw# 2210968-2020-03131.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: chirurgia (2019) 114: 57-66 doi: http://dx.Doi.Org/10.21614/chirurgia.114.1.57.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 product (ultrapro mesh) 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 product involved? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: postoperative outcomes and patients¿ satisfaction after hybrid tipp with uhs and tep repair for inguinal hernias: a single-centre retrospective comparative study.This single-center, retrospective comparative study aims to compare the outcomes and satisfaction of hybrid transabdominal preperitoneal (htipp) procedure using ultrapro hernia system (ethicon).From 2013-2017, 90 patients had either htipp (n=46) or totally extraperitoneal (tep) (n=44) inguinal hernia repairs.During the hybrid transabdominal preperitoneal (htipp) procedure, the underlay part of the mesh of ultrapro hernia system (ethicon) was folded then inserted into preperitoneal space through the internal ring.Surgical manipulation was used for proper deployment of the underlay part of the mesh and for confirming the proper expansion and the entire covering of the myopectineal orifice (mpo).The onlay part of the mesh was used to cover and reinforce the floor of the inguinal canal.The onlay mesh was modified to accommodate the cord structure and was fixed with interrupted absorbable sutures with the longer side of the onlay being positioned parallel to the inguinal ligament.Immediate postoperative complications included postoperative pain (vas score within 24 hours) of 3 (range of 1-7) (n=unknown), urine retention (n=2) requiring urinary catheter insertion, bronchospasm (n=1) and severe postoperative pain requiring admission for pca (n=1).During the early period, testicular pain on the ipsilateral side of the surgery (n=2), pain on the surgery site demanding analgesia for longer duration (n=2) and subcutaneous wound seroma (n=1) were reported.The late complication for htipp patients is mainly inguinal discomfort/pain (n=3) that did not require long term treatment and without significant impact on daily activities.Based on the outcome of the study¿s questionnaire applied from the follow-up of 6-56 months, patients had a lot of pain/discomfort (n=3), some discomfort (n=7), problems walking (a lot of problems n=1 and some problems n=1), have some problems looking after myself (n=3), problems doing daily activities (a lot of problems n=1 and some problems n=5) and feeling worried (very worried n=1 and bit worried n=1).There is no significant difference between htipp and tep in terms of postoperative outcomes and patient satisfaction.Htipp approach is a safe and feasible alternative to tep.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11362750
• MDR Text Key: 233291831
• Report Number: 2210968-2021-01686
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ULTRAHSUNK
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention