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

Patient Problems Purulent Discharge (1812); Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Sepsis (2067); Hernia (2240); Peritonitis (2252); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product: abstack20 5mm sgl use abs dev 20 tacks (lot# nim213). 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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after implant, the patient experienced hypotensive, septic, recurrence, purulent material, purulent ascitic fluid, necrosis, dilated small bowel with distal compression, and peritonitis. Post-operative patient treatment included revision surgery, bowel resection, abdominal washout, small bowel resection, umbilical washout/drainage, resection/irrigation, skin left open and packed with kerlix, and mesh removal.

• 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: 11546195
• MDR Text Key: 241726276
• Report Number: 9615742-2021-00616
• 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

• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 08/31/2013
• Device Model Number: PCO9
• Device Catalogue Number: PCO9
• Device Lot Number: PII00049
• 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: 04/28/2021
• 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: 03/22/2021 Patient Sequence Number: 1