MAUDE Adverse Event Report: MESH; MESH, SURGICAL, POLYMERIC

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Urinary Tract Infection (2120)

Event Date 06/07/2016

Event Type  Injury  

Event Description

Chronic infections and pain; had a gynecological surgery in (b)(6) 2014 with mesh placement.I've had chronic uti, pain, and urinary related issues.It has caused so many problems and i was unaware that the product that was supposed to improve life would cause life changing issues.Fda safety report id# (b)(4).

• Brand Name: MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• MDR Report Key: 12008130
• MDR Text Key: 256772573
• Report Number: MW5101918
• Device Sequence Number: 1
• Product Code: FTL
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem 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): Hospitalization; Other; Disability
• Patient Age: 32 YR
• Patient Weight: 61