MAUDE Adverse Event Report: UNKNOWN VAGINAL MESH

Device Problems Material Erosion (1214); Device Issue (2379)

Patient Problems Erosion (1750); Inflammation (1932); Pain (1994)

Event Date 12/14/2016

Event Type  Injury  

Event Description

Patient complained of difficulty urinating secondary to eroded mesh.A small piece of mesh was excised from the urethra.

• Brand Name: VAGINAL MESH
• Type of Device: VAGINAL MESH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5427421
• MDR Text Key: 38081623
• Report Number: 5427421
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/26/2016,12/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2016
• Distributor Facility Aware Date: 01/14/2016
• Device Age: 4 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 67