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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Type  Injury  

Event Description

Bladder prolapse second time, foul vaginal odor in pain, etc.Vaginal mesh.Reoccurring utis, bladder prolapse again, vaginal odor and pain.Fda safety report id # (b)(4).

• Brand Name: VAGINAL MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9775254
• MDR Text Key: 181956481
• Report Number: MW5093433
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 43 YR
• Patient Weight: 77