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

Model Number UNKNOWN MESH PRODUCT

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

Patient Problems Pain (1994); Discomfort (2330); Swelling/ Edema (4577)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

Title: surgical procedures and results of modified intraperitoneal onlay mesh repair for inguinal hernia after radical prostatectomy source: journal of laparoendoscopic & advanced surgical techniques volume 30, number 11, 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of a study performed between february 2013 and january 2020 about surgical procedures and results of modified intraperitoneal onlay mesh repair for inguinal hernia after radical prostatectomy, 57 patients underwent laparoscopic surgery for inguinal hernias after radical prostatectomy where a composite mesh and a mesh with collagen film were used.44 out of 57 patients underwent transabdominal preperitoneal (tapp) repair.The remaining 13 patients underwent modified intraperitoneal onlay mesh (ipom).Early post-operative complications include pain, discomfort, and inguinal swelling.1 patient in the tapp group complained of inguinal region discomfort at 6 months or later after the surgery.There was also 1 patient in the modified ipom group that had late post-operative discomfort.

• Brand Name: UNKNOWN MESH PRODUCT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12288047
• MDR Text Key: 265395252
• Report Number: 9615742-2021-01903
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN MESH PRODUCT
• Device Catalogue Number: UNKNOWN MESH PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• 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