MAUDE Adverse Event Report: SOFRADIM PRODUCTION SYMBOTEX COMPOSITE MESH; MESH SURGICAL

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Incontinence (1928); Unspecified Infection (1930); Pain (1994); Hernia (2240); Sensitivity of Teeth (2427)

Event Type  Injury  

Event Description

Issues with mesh used to repair hernia.Intestinal infection, pain, inability to use bathroom, tooth decay, hernia reoccurrence.

• Brand Name: SYMBOTEX COMPOSITE MESH
• Type of Device: MESH SURGICAL
• Manufacturer (Section D): SOFRADIM PRODUCTION
• MDR Report Key: 6879349
• MDR Text Key: 86830235
• Report Number: MW5072231
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 47 YR
• Patient Weight: 66