MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); Pain (1994)

Event Type  Injury  

Event Description

It was reported by the patient that he had an advance sling implanted 4 1/2 years ago and he is using "at least 3 pads a day and 1 at night." recently he has had pain in his groin area and had a ct scan done which revealed initially "it was fine," however he is still awaiting final results.No additional patient complications have been reported in relation to this event.

• Brand Name: AMS ADVANCE MALE SLING SYSTEM
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 4224698
• MDR Text Key: 4995284
• Report Number: 2183959-2014-00490
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability