MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS / BOSTON SCIENTIFIC CORPORATION MINIARCH SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Unspecified Infection (1930); Pain (1994); Dysuria (2684); Urinary Incontinence (4572)

Event Date 10/11/2016

Event Type  Injury  

Event Description

I received a mesh bladder sling in 2016.Since surgery i have had multiple problems including constant infections, pelvic pain, inability to be sexually active due to pain.Trouble urinating and so on.I recently discovered after 4 years of suffering that the mesh has malfunctioned and i am now requiring a 3rd surgery for removal of the device.Urinary incontinence, urge - primary icd-10-cm: n39.41 icd-9-cm: 788.31, dysfunctional voiding of urine, icd-10-cm: n39.8 icd-9-cm: 599.9.Fda safety report id# (b)(4).

• Brand Name: MINIARCH SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS / BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10739894
• MDR Text Key: 213448363
• Report Number: MW5097454
• Device Sequence Number: 1
• Product Code: PAG
• 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: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• 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; Disability
• Patient Age: 35 YR
• Patient Weight: 109