MAUDE Adverse Event Report: ETHICON INC. PROCEED MESH; MESH, SURGICAL, POLYMERIC

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

Patient Problems Abdominal Pain (1685); Hernia (2240)

Event Date 12/01/2018

Event Type  Injury  

Manufacturer Narrative

Product complaint (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, demographics regarding the additional events.Citation cite: surgical endoscopy.Conference: 26th international congress of the european association for endoscopic surgery, eaes 2018.London united kingdom.32(supplement 2) (pp s484), 2018.Date of publication: december 2018 http://dx.Doi.Org.Ezjnj04.Infotrieve.Com/10.1007/s00464.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Events were submitted via 2210968-2021-04853.

Event Description

Title: 'slim-mesh': a new laparoscopic technique for the treatment of abdominal wall hernias.The first mid-term results.This study was designed for a new laparoscopic fixation technique ("slim-mesh", sm) to treat abdominal wall hernias (awh) without the use of transabdominal full-thickness stitchesin order to reduce surgical time, acute and chronic pain, or other associated complications.Between 2009 and october 2017, 60 consecutive patients with abdominal wall hernias (awh) were treated at padua university hospital with a new approach called the sm technique.Data on all patients were collected retrospectively (55%) or prospectively (45%).This study comprised 50 percent males with patient age averaging (b)(6) years old (range: (b)(6) years old).A composite mesh (proceed ,ethicon) (85%) and dual mesh (5%)) up to 30cm was used in 90% of patients while a non-composite mesh (bibraun omyra) was used for the remainder (10%).Securestrap (ethicon) was the fixation device used in 75% of cases.Mean length of hospital stay was 3 days.Mean follow-up time was 32 months (range: 1-98 months).Reported complications included hernia recurrence (n=4) all four patients underwent surgery., abdominal pain (n=1) the patient underwent a second laparoscopy, but no related sm repair complications were found.In conclusion this new surgical technique for awh repair simplifies intra-abdominal introduction, well as mesh handling and fixation because it does not require transfascial sutures or other expensive alternatives.The sm technique is, in our experience, simple,safe and fast.

• Brand Name: PROCEED MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11862991
• MDR Text Key: 265205845
• Report Number: 2210968-2021-04854
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060713
• 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: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• 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: 05/11/2021
• 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