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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/20/2010

Event Type  Injury  

Event Description

It was reported that during an initial implant of a non-specified sling, the intended sling that was initially prepared for the implant "was too small" and the surgery was prolonged as another sling was obtained from a different location.An advance sling was implanted for the desired outcome.No patient complications were reported in relation to this event.Related to manufacturer's report # 2183959-2015-00221.

• 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: 4817594
• MDR Text Key: 5901333
• Report Number: 2183959-2015-00224
• Device Sequence Number: 1
• Product Code: FTL
• 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: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2015
• 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
• Patient Age: 68 YR