MAUDE Adverse Event Report: TRANSVAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYCECOLOGIC, FOR PELVIC ORGAN PROLAPSE TRANSVAGINA

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Pain (1994); No Code Available (3191)

Event Date 02/01/2018

Event Type  Injury  

Event Description

Transvaginal mesh implant surgery on (b)(6) 2018 to correct stress urinary incontinence and pelvic organ prolapse.Following surgery, incontinence, abdominal pain, pain during intercourse were present until (and following) removal of the tvm on (b)(6) 2019.Fda safety report id# (b)(4).

• Brand Name: TRANSVAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYCECOLOGIC, FOR PELVIC ORGAN PROLAPSE TRANSVAGINA
• MDR Report Key: 9147102
• MDR Text Key: 161364297
• Report Number: MW5090185
• Device Sequence Number: 1
• Product Code: OTP
• 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: 09/29/2019
• 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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 93