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

Model Number UNKNOWN PERMACOL PRODUCT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Incontinence (1928); Necrosis (1971); Pain (1994); Hernia (2240); Post Operative Wound Infection (2446); Bowel Perforation (2668); No Code Available (3191)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Title further insights into the treatment of perineal hernia based on a the experience of a single tertiary centre source the authors.Colorectal disease published by john wiley & sons ltd on behalf of association of coloproctology of great britain and ireland, volume 22, 2020 (694¿702) date of online acceptance: 8 january 2020.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature source of a study performed about the evolution of a technique for repair of perineal hernia by analyzing the experience in a tertiary referral center, biological mesh was used in 18 out of a total 34 patients.A cross-linked biological mesh was used in 4 out of the 18 patients and complications were noted.1 patient underwent relaparotomy because of iatrogenic small bowel perforation following adhesiolysis.There were 5 patients that had perineal wound complications.3 had dehiscence, 2 had infection, and 1 had necrosis.All perineal wound infections were successfully treated with antibiotics (2) and percutaneous drainage of fluid collections (1).There were 7 recurrent perineal hernia after a median of 33 months, where recurrence of perineal hernia occurred in 1 out of 4 patients with cross-linked biological mesh.Re-repair after failed biological mesh using transperineal synthetic mesh was performed in four of seven patients.One patient with a cross-linked biological mesh had developed urinary incontinence and pain in a standing position caused by displacement of the mesh, which was treated by laparoscopic re-fixation of the mesh.Perineal infection occurred in one more patient after biological mesh repair following re-repair of a recurrence and was treated by antibiotics.

• 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: 10428996
• MDR Text Key: 203862905
• Report Number: 9615742-2020-01849
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• 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: 08/03/2020
• 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