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

Model Number UNK-M-1008380

Device Problem Fluid/Blood Leak (1250)

Patient Problem Incontinence (1928)

Event Date 05/21/2019

Event Type  Injury  

Event Description

It was reported that the patient had terrible experience with a male sling system.The patient stated the sphincter is tightly closed, but the bladder doesn't have the power to empty.He catheterizes himself now, and before that he had an indwelling catheter.The urine seeps out even though he can't urinate his own.He is currently taking flomax and he has been on several other drugs.He will see the doctor again on (b)(6) 2019.He is also thinking about seeking a second opinion on this issue.

• Brand Name: AMS ADVANCE 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 10700 bren road w; ,; minnetonka MN 55343
• Manufacturer Contact: mike bocchino ; 10700 bren road w; ,; minnetonka, MN 55343 ; 6515827161
• MDR Report Key: 8667911
• MDR Text Key: 146964587
• Report Number: 2183959-2019-63693
• 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: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/04/2019

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: UNK-M-1008380
• Device Catalogue Number: UNK-M-1008380
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 06/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention