MAUDE Adverse Event Report: ETHICON INC. PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

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

Patient Problems Hematoma (1884); Pain (1994)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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: british journal of surgery.2021 oct; conference: association of surgeons of great britain and ireland congress.Virtual.108(suppl 7) :vii44.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article with title: consenting practice in open inguinal hernia mesh repair and compliance with the british hernia society standards.This retrospective study analyses open inguinal hernia repair (ihr) consent practice against british hernia society standards, in particular, whether the term 'mesh' and significant postoperative complications were stated on consent forms.We also identified whether adequate postoperative advice was given upon discharge in order to prevent recurrence.A total of 94 patients who underwent open ihr between january 1 to december 31, 2019 were included in the study.Although in all cases a prolene mesh was inserted, 8.5% of patients received no mention of mesh in either the clinic letter or consent form.Reported complications include postoperative readmission (n=5.3%) at one week, and (n=8.5%) at one month due to pain (n=1%) and haematoma (n=2%).In conclusion, adherence to consenting standards benefits both patients and doctors.Our study highlights that further intervention is required to ensure surgeons are consenting patients adequately, as well as providing sufficient postoperative advice.We advise use of pre-filled forms and patient information leaflets, both in line with gmc guidance, to improve the quality of service offered.

• Brand Name: PROLENE POLYPROPYLENE MESH UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13565030
• MDR Text Key: 289317629
• Report Number: 2210968-2022-01199
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K962530
• 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
• Report Date: 02/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention