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.

• 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: 8733241
• MDR Text Key: 149160561
• Report Number: 9615742-2019-02292
• 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,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN-PERMACOL
• Device Catalogue Number: UNKNOWN-PERMACOL
• 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: 06/04/2019
• 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: 06/26/2019 Patient Sequence Number: 1