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

Model Number P151520

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

Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Adhesion(s) (1695); Unspecified Infection (1930); Inflammation (1932); Necrosis (1971); Pain (1994); Scar Tissue (2060); Cramp(s) (2193); Hernia (2240); Discomfort (2330); Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of an incisional hernia. It was reported that after the onlay implant, the patient experienced adhesions, recurrence, abdominal pain, exacerbation, crampy associated with meals, contracted scar tissue, painful left side pannus with panniculitis, inflammation, necrosis, discomfort, pain, and infection. Post-operative patient treatment included revision surgery with additional implant, reconstruction of midline ventral hernia with left sided muscle flap, direct repair of left incisional hernia, abdominal panniculectomy, explantation of retained abdominal mesh with sutures, complex repair, removal of contracted scar tissue, removal of mesh, dermal/fat graft to abdominal wall, complex repair of abdominal wall skin defect, removal of hernia sac, hernia repaired in a vest over pants style, and lysis of adhesions.

• Brand Name: 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: 9883808
• MDR Text Key: 185912197
• Report Number: 9615742-2020-00649
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/17/2009
• Device Model Number: P151520
• Device Catalogue Number: P151520
• Device Lot Number: 06B10-1
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/04/2020
• 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: 03/26/2020 Patient Sequence Number: 1