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 Adhesion(s) (1695); Fistula (1862); No Code Available (3191)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

Recurrent intestinal fistulation after porcine acellular dermal matrix reinforcement in enteric fistula takedown and simultaneous abdominal wall reconstruction r.Kalaiselvan1 · g.L.Carlson1 · s.Hayes1 · n.P.Lees1 · i.D.Anderson1 · d.A.J.Slade1 springer-verlag france sas, part of springer nature 2019 published online: 06 december 2019.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Pli10 - according to literature source of study to assess the mechanism for failure of porcine acellular dermal matrix (padm) in intestinal and abdominal wall reconstruction (awr) for enterocutaneous fistulation (ecf), thirteen patients were included in the study and device was used as a reinforcing prosthetic in abdominal wall repair.In all cases, porcine acellular dermal matrix had been used to bridge the defect and placed in direct contact with bowel.Twelve of the thirteen patients had developed abdominal wall defects (awd) and ecf following complications of previous surgery.Some of the patients underwent fistula takedown and awr with padm, of which five refistulated while some of the patients referred to us had already undergone similar procedures in their referring hospitals and had also refistulated.At reconstructive surgery for refistulation, porcine acellular dermal matrix was inseparable from multiple segments of small intestine, necessitating extensive bowel resection.Histological examination confirmed that the padm almost completely integrated with the seromuscular layer of the small intestine.

• 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: 9716635
• MDR Text Key: 187617413
• Report Number: 9615742-2020-00376
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2020
• 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: 58 YR