MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) UNKNOWN SLING

Device Problem Extrusion (2934)

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

Event Date 07/24/2014

Event Type  Injury  

Event Description

It was reported that the patient underwent surgery for "excision of vaginal sling" due to a "small exposure" near the bladder neck.The physician only removed a small piece of mesh that was exposed.No patient complications have been reported in relation to this event.

Manufacturer Narrative

The manufacturer and brand of the pelvic mesh product implanted is unknown.

• Brand Name: UNKNOWN SLING
• Type of Device: UNKNOWN
• 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: 3967640
• MDR Text Key: 4637567
• Report Number: 2183959-2014-00337
• 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: 07/11/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 07/30/2014
• 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): Hospitalization; Required Intervention