MAUDE Adverse Event Report: MONARC SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Miscarriage (1962); Pain (1994); Prolapse (2475); Constipation (3274)

Event Date 07/23/2019

Event Type  Injury  

Event Description

Got transvaginal mesh for pop and urinary incontinence.Have had bleeding pain, return of prolapse, lost a daughter at (b)(6) due to infection, and also been diagnosed with primary progressive multiple sclerosis, lucky if i have a bowel movement once a week.Fda safety report id# (b)(4).

• Brand Name: MONARC SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• MDR Report Key: 8930319
• MDR Text Key: 155505106
• Report Number: MW5089287
• Device Sequence Number: 1
• Product Code: OTN
• 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: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 37 YR
• Patient Weight: 57