MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROGRIP; MESH, SURGICAL, POLYMERIC

Model Number TEM1515G

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

Patient Problems Abdominal Pain (1685); Ischemia (1942); Thrombosis (2100); Injury (2348); Impaired Healing (2378); Respiratory Failure (2484)

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 incisional umbilical hernia.It was reported that after implant of the device, the patient experienced issues that included open wound.Treatment for these issues involved application of wound vac, small bowel resection with anastomosis and enterotomy, abdominal wall closure, and placement of new mesh.After these treatments, the patient experienced vent-dependent respiratory failure from undergoing exploratory laparotomy for sma thrombosis and resection of almost the entirety of their small bowel.Provided medical records show that one week after implant of the device, the patient experienced significant issues with abdominal pain, acute mesenteric ischemia, venous congestion and thrombosis.No specific mesh-related issues were noted, and the ischemia / thrombosis treatment that spanned multiple days of icu hospitalization included removal of the mesh.Approximately two weeks after removal, new vicryl mesh was implanted.

• Brand Name: PROGRIP
• 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: 8939441
• MDR Text Key: 155801187
• Report Number: 9615742-2019-02891
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10884521177727
• UDI-Public: 10884521177727
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081050
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: TEM1515G
• Device Catalogue Number: TEM1515G
• Device Lot Number: SOE0129X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2019
• Initial Date FDA Received: 08/28/2019
• Date Device Manufactured: 05/21/2014
• 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): Hospitalization; Life Threatening; Required Intervention