MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS SURGIPRO; MESH, SURGICAL, POLYMERIC

Model Number UNKNOWN SURGIPRO MESH

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

Patient Problems Cardiac Arrest (1762); Exsanguination (1841); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Blood Loss (2597); No Code Available (3191)

Event Date 01/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(re operation).Title: laparoscopic posterior mesh rectopexy for rectal prolapse is a safe procedure in older patients: a prospective follow-up study source scandinavian journal of surgery, volume 104, 2015 (227¿232) article number: 7 date of publication: 19 november 2014.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between february 01, 2009 to june 01, 2012 in a tertiary center in denmark 81 eligible patients underwent laparoscopic posterior rectopexy (lpr) with application of the mesh device and secured with four to eight titanium tacks and were followed up to two years with major complications seen in twelve patients (14.8%) with the first three that could be related to the procedure or the device.Four patients had bleeding (4.9%), five patients had small bowel obstruction (6.2%), one patient had deep would infection (1.2%), one patient had cardiac arrest (1.2%).These major complications were those that required admission more than three days, re-operation, blood transfusion.

• Brand Name: SURGIPRO
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 8962812
• MDR Text Key: 156802152
• Report Number: 9615742-2019-02994
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN SURGIPRO MESH
• Device Catalogue Number: UNKNOWN SURGIPRO MESH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/04/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 73 YR