MAUDE Adverse Event Report: MEDTRONIC / SOFRADIM PRODUCTION SYMBOTEX MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994); Hernia (2240); Paresthesia (4421)

Event Date 07/20/2022

Event Type  Injury  

Event Description

Indwelling intraperitoneal symbotex mesh fused to small bowel.The patient underwent implantation, on two separate occasions, of symbotex mesh placed in the intraperitoneal position ((b)(6) 2019 and (b)(6) 2021).She developed a symptomatic recurrent incisional hernia after the last implantation.Her symptoms included severe pain and functional disability.At the time of explantation on (b)(6) 2022, the previous meshes were found to be fused to a portion of her small intestine requiring bowel resection as well as complete mesh explantation.She underwent a complex operation and had a complicated postoperative course which could have been avoided, had she not had the recurrence and not have the fusion of mesh to the small bowel.Fda safety report id # (b)(4).

• Brand Name: SYMBOTEX MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): MEDTRONIC / SOFRADIM PRODUCTION
• MDR Report Key: 15527811
• MDR Text Key: 301118870
• Report Number: MW5112372
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2022
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White