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

Model Number UNKNOWN-PERMACOL

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

Patient Problems Abscess (1690); Cellulitis (1768); Post Operative Wound Infection (2446); No Code Available (3191)

Event Date 08/13/2013

Event Type  Injury  

Manufacturer Narrative

Title failure to obtain microbiological culture and its consequence in a mesh-related infection source bmj case rep, 2013 (1-3).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a (b)(6) years old patient had acute cholecystitis, gallstone pancreatitis and cholangitis.Which lead to her having percutaneous biliary drainage followed by an open cholecystectomy procedures.Four months post-operative of the aid surgeries, the patient had developed an incisional hernia which was addressed with subsequent laparoscopic repair using a composite mesh.Patient was presented in the emergency room with signs of abscess with surrounding cellulitis of the abdomen a year after the hernia repair.The mesh was removed and patient was implanted with a biological mesh and was provided with antibiotics tailored to the offending pathogen identified postoperative culture of the infected mesh.

Manufacturer Narrative

This event has been reassessed and found to be a non-mdr reportable complaint.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MESH TSL - PERMACOL¿
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• MDR Report Key: 8733241
• MDR Text Key: 149160561
• Report Number: 9615742-2019-02292
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

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-PERMACOL
• Device Catalogue Number: UNKNOWN-PERMACOL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR