MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANCE MALE SLLING; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Incontinence (1928)

Event Type  Injury  

Event Description

Urinary incontinence; the advance male sling implant failed after two years.None of the company's literature that i received mentioned the possibility of failure.Fda safety report id # (b)(4).

• Brand Name: ADVANCE MALE SLLING
• Type of Device: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 10137676
• MDR Text Key: 194779734
• Report Number: MW5094907
• 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: 06/05/2020

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 70 YR
• Patient Weight: 75