MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL¿ MESH, SURGICAL

Model Number UNKNOWN PERMACOL PRODUCT

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

Patient Problems Pulmonary Embolism (1498); Abscess (1690); Cellulitis (1768); Necrosis (1971); Hernia (2240); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 10/04/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4). Title outcomes of complex abdominal herniorrhaphy. Source annals of plastic surgery. Volume 68, number 4, april 2012. Received october 2, 2011, and accepted for publication, after revision, october 4, 2011. If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source study performed on 185 patients who underwent ventral hernia repair. A total of 106 patients were included. Thirty patients received synthetic meshes while 76 patients received biologic mesh. Results and complications were not reported based on mesh type so all complications were all pooled together. Sixty-seven patients developed a postoperative complication (63%). Skin necrosis was the most common complication. Other complications included seroma, cellulitis, abscess, pulmonary embolus/deep vein thrombosis, small bowel obstruction, and fistula. Thirty patients required reoperations because of postoperative complications. Seventeen patients developed recurrences.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• 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: 8801031
• MDR Text Key: 151415211
• Report Number: 9615742-2019-02587
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/17/2019 Patient Sequence Number: 1