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

Model Number UNK-P-SLING-MENS

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent a surgical procedure to revise this male sling system due to unspecified reasons.The sling remains implanted and a new artificial urinary sphincter (aus) was implanted.

Event Description

It was reported that the patient underwent a surgical procedure to revise a non-bsc male sling system due to unspecified reasons.The sling remains implanted and a new artificial urinary sphincter (aus) was implanted.

Manufacturer Narrative

Correction: the male sling is not a bsc male sling system.

• Brand Name: AMS SLING SYSTEM
• Type of Device: MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; minnetonka MN 55343
• MDR Report Key: 11210785
• MDR Text Key: 228153474
• Report Number: 2183959-2021-00080
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

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
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/21/2021
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention