MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINNETONKA AMS ADVANCE MALE SLING SYSTEM; MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE

Catalog Number	720088-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Incontinence (1928)
Type of Reportable Event	Serious Injury
Event or Problem Description
Following the implantation of an advance sling, the patient experienced "erosion of the mesh" and the incontinence became worse.The patient was implanted with another incontinence device.No further patient complications were reported in relation with this event.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Common Device Name: MESH, SURGICAL, FOR STRESS URINARY INCONTINENCE, MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINNETONKA; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 7198512
• Report Number: 2183959-2018-00014
• Device Sequence Number: 19086844
• Product Code: OTM
• UDI-Device Identifier: 00878953005300
• UDI-Public: 00878953005300
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/12/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 720088-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2018
• Initial Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention