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 Wound Dehiscence (1154); Fever (1858); Seroma (2069); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Title: the use of permacol® biological mesh for complex abdominal wall repair 2021 source: minerva surgery 2021 apr 23.Doi: 10.23736/s2724-5691.21.08779-4 article type: original article, 2021 edizioni minerva medica.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study evaluated the safety and efficacy of reported mesh in patients who underwent complex abdominal wall repair (cawr) between january 2009 and december 2018.It was noted that the mesh was placed either via inlay, sublay, or underlay.There were 75 patients included in the study, and complications included seroma.Computed tomography (ct) guided drainage was performed for collections, superficial surgical site infections managed with local treatment and antibiotics, profound surgical site infection treated with re-operation for lavage and mesh removal in one patient.Ct guided drainage in two additional patients, superficial wound dehiscence, which ultimately led to mesh removal and post-operative fever.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 11968755
• MDR Text Key: 255445872
• Report Number: 9615742-2021-01439
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PERMACOL PRODUCT
• Device Catalogue Number: UNKNOWN PERMACOL PRODUCT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 30