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

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/18/2016

Event Type  Injury  

Manufacturer Narrative

One tried, not used advance sling was returned.The sling is outside of the sheath and the sheath was not returned.The sling is stretched on both sides of the middle section.It is partially torn on one side of the middle section and completely torn on the other side of the middle section.

Event Description

It was reported that an advance sling was tried but not used due to "broke while tensioning." on (b)(6) 2016, it was reported that the sling broke while tensioning, and that the surgery was prolonged due to the sling "breaking during tensioning." another sling was implanted.No additional patient complications were 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: 5586461
• MDR Text Key: 42944040
• Report Number: 2183959-2016-00104
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 76 YR