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

Model Number UNK-P-SLING-MENS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Incontinence (1928); No Code Available (3191)

Event Date 09/18/2018

Event Type  Injury  

Event Description

It was reported that the patient had an advance sling implanted in 2010.The patient was implanted with an alternative continence device on (b)(6) 2018.

Manufacturer Narrative

Additional information.

Event Description

It was reported that the patient had an advance sling implanted in 2010.The patient was implanted with an alternative continence device on (b)(6) 2018.Additional information received indicated the patient was seen by the physician for the first time (b)(6) 2018 and stated the sling had never worked effectively and the incontinence was uncontrolled.Following the implant of the alternative incontinence device, it was reported the patient was happy and controlled continence has returned.

• Brand Name: AMS MALE 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: 7981424
• MDR Text Key: 124297337
• Report Number: 2183959-2018-60245
• 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: 03/28/2019

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
• Device Model Number: UNK-P-SLING-MENS
• Device Catalogue Number: UNK-P-SLING-MENS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 02/27/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR