MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH MESH, SURGICAL, POLYMERIC

Model Number PCO9

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Adhesion(s) (1695); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Pain (1994); Hernia (2240); Peritonitis (2252); Injury (2348); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

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 a umbilical hernia by laparoscopic repair. It was reported that after implant, the patient experienced infection, three intra-abdominal abscesses, adhesions, hernia recurrence, mesh migration, mesh contraction, bowel perforation, chronic abdominal pain, inflammatory changes, peritonitis, post-operative patient treatment included revision surgery for excision of mesh, ascending colectomy and end ileostomy creation, lysis of adhesions, drainage of abscesses, abdominal washout, and mucus fistula creation. Medical records noted moderate amount of bleeding due to manipulation of inflamed tissues during the revision surgery and patient was subsequently transferred to icu.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 9000783
• MDR Text Key: 158089712
• Report Number: 9615742-2019-03098
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040998
• 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,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PCO9
• Device Catalogue Number: PCO9
• Device Lot Number: B22291
• 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: 09/18/2019
• 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: 09/11/2019 Patient Sequence Number: 1