MAUDE Adverse Event Report: ASPIDE MEDICAL SURGIMESH ; MESH, SURGICAL, POLYMERIC

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Fever (1858); Pain (1994)

Event Date 09/10/2017

Event Type  Injury  

Event Description

Pt stated that roughly 4 weeks after the initial surgery, he started having pain and lump reappearance, and only had comfort when laying down, while standing up and walking meant excruciating pain.Pt had two f/u appts to address the symptoms.During the first f/u appt, pt states that he was sitting for 45 mins waiting for the dr and therefore, the lump and pain symptoms were not apparent for the dr.The dr arrived and did a quick palpation of the area and told the pt he was fine.The pt came back for a second f/u but instead during this time chose to wait for the dr standing in order to show the dr that his symptoms were true.By the time, the dr appeared, the pt was bunched in pain and the dr did an examination to determine that the mesh wasn't functioning as intended.The dr recommended physical therapy as a result and the pt completed it but it only resulted in more pain.The pt also notes that he is not overweight, takes care of himself, does not smoke, walks everyday, and is healthy for his age.The pt also delineated that the initial surgery was laparoscopic and the revision surgery ((b)(6) 2017) was performed via incision.During the revision surgery, the surgeon did not remove the faulty mesh but instead put another mesh on top of it.After the revision, the pt began experiencing body aches and had a fever with a temperature of 104.The drs were only able to diagnose a fever for the pt and were not able to link it to the mesh.Since then, the pt has had daily pain and feels pain doing everyday activities such as work around the house, walking, and pain during intercourse two years later.

• Brand Name: SURGIMESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASPIDE MEDICAL
• MDR Report Key: 8749159
• MDR Text Key: 149807974
• Report Number: MW5087705
• 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: 06/28/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88