MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC TRANSVAGINAL MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Device Problems Patient-Device Incompatibility (2682); Appropriate Term/Code Not Available (3191)

Patient Problems Micturition Urgency (1871); Pain (1994); Hematuria (2558)

Event Date 07/20/2017

Event Type  Injury  

Event Description

Transvaginal mesh placed vaginally for pop.Immediately began to experience urinary pain and leakage.Mesh was removed (b)(6) 2019 in a 10 hour surgery.It had caused extensive damage.To this day i have pain, urgency, frequency and bleeding with urination.Fda safety report id (b)(4).

• Brand Name: BOSTON SCIENTIFIC TRANSVAGINAL MESH
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 11337649
• MDR Text Key: 232888246
• Report Number: MW5099429
• 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: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 58