MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. ADVANCE TRANSOBTURATOR MALE SLING; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE

Device Problem Device Inoperable (1663)

Patient Problem Incontinence (1928)

Event Date 02/28/2016

Event Type  Injury  

Event Description

The advance transobturator male sling began a slow fail after six years.The sling was designed to alleviate urinary stress incontinence, and it worked since the sling was inserted in (b)(6) 2010.My incontinence grew progressively worse until mid-summer of 2016 when the amount of urine i leaked was the same as before the sling was inserted.

• Brand Name: ADVANCE TRANSOBTURATOR MALE SLING
• Type of Device: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP.
• MDR Report Key: 7439441
• MDR Text Key: 105916422
• Report Number: MW5076531
• Device Sequence Number: 1
• Product Code: OTM
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR
• Patient Weight: 76