MAUDE Adverse Event Report: ASPIDE MEDICAL / CHAMBERLAIN TECHNOLOGIES, LLC. SURGIMESH XB; MESH, SURGICAL, POLYMERIC

Model Number TINTRACK10

Device Problem Use of Device Problem (1670)

Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 08/23/2018

Event Type  Injury  

Event Description

Implanted with a surgimesh xb on (b)(6) 2017 for supraumbilical ventral hernia repair.Then developed an enterocutaneous fistula, mesh infection, and open draining wound on or about (b)(6) 2017.On (b)(6) 2018, underwent open surgery to remove the infected mesh, take down the fistula, and drain the abscess."there was a fistula tracking from the umbilicus down to the abscess cavity.The mesh was clearly involved and had not incorporated at all." continued to suffer an abscess following the procedure, which he underwent another incision and drainage on (b)(6) 2008.A case was filed against the manufacturer aspide medical.However, aspide medical does not appear to be operating any longer.It did not file a maude report, failed to answer the complaint in federal court, and does not appear to be engaging in any post-market surveillance of these devices.It is highly alarming that these devices are no longer being monitoring for safety by any entity.We are requesting the fda confirm why no person or entity is engaging in post-market surveillance of these devices.We represent multiple other consumers who have also filed personal injury lawsuits regarding these devices and none of their events have been reported as adverse events.

• Brand Name: SURGIMESH XB
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL / CHAMBERLAIN TECHNOLOGIES, LLC.
• MDR Report Key: 16552514
• MDR Text Key: 311490713
• Report Number: MW5115775
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: TINTRACK10
• Device Catalogue Number: TINTRACK10
• Device Lot Number: F14098A
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic