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

Model Number	720088-01
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure, on the right side, the male sling rip in half were the physician could have cut.The sling remains implanted.No information about the patient outcome is available at the moment.Should additional information be received, a supplemental report will be submitted.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Common Device Name: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 8847784
• Report Number: 2183959-2019-65416
• Device Sequence Number: 14057764
• Product Code: OTM
• UDI-Device Identifier: 00878953005300
• UDI-Public: 00878953005300
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/01/2019
• Device Model Number: 720088-01
• Device Catalogue Number: 720088-01
• Device Lot Number: 1000255777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 07/31/2019
• Patient Sequence Number: 1
• Patient Age: 72 YR