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

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

Patient Problems Hematoma (1884); Pain (1994); Numbness (2415)

Event Date 11/01/2021

Event Type  Injury  

Event Description

It was reported in a journal article with title: efficacy of two kinds of treatment for adult inguinal hernia and the effect on postoperative femoral vein blood flow velocity and pain.The aim of this retrospective study is to observe the effects of progrip self-fixing patch + lichtenstein surgery and uhs patch + tension-free preperitoneal space repair (gilbert surgery) in the treatment of adult inguinal hernias and their influence on postoperative femoral vein blood flow velocity and pain.A total of 149 patients with inguinal hernia who received treatment from january 2018 to january 2020 were included.These patients were divided into lichtenstein patch group (70 cases; 63 male and 7 female) and gilbert patch group (79 cases; 67 male and 12 female) according to different surgical intervention regimens.The lichtenstein patch group was given progrip self-fixing patch + lichtenstein surgery (patch: produced by covidien, usa), and the gilbert patch group was given uhs patch + gilbert surgery (patch: produced by johnson & johnson, usa).Reported complications include hematoma (n=8), chronic pain (n=4), and incision numbness (n=8).In conclusion, progrip self-fixing patch + lichtenstein surgery and uhs patch + gilbert surgery have good therapeutic effects in the treatment of adult inguinal hernias.Compared with uhs patch + gliber surgery, progrip self-fixing patch + lichtenstein surgery has a shorter surgical time, lower incidence rate of postoperative hematomas, but a higher incidence rate of chronic pain.

Manufacturer Narrative

Product complaint # (b)(4).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.(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: shaanxi medical journal (november 2021); 50 (11): 1367-1370.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 ethicon product (ultrapro hernia system) involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon product has been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with the ethicon product involved? patient demographics.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15298407
• MDR Text Key: 298659840
• Report Number: 2210968-2022-06946
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other