MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC PRECISE SINGLE-INCISION SLING; MESH, SURGICAL, POLYMERIC

Catalog Number 720191-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff died.It was also reported that the plaintiff allegedly experienced emotional distress and a product problem.No cause of death was reported.

Manufacturer Narrative

Lawyer-filed report.

• Brand Name: AMS MINIARC PRECISE SINGLE-INCISION SLING
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd., west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, director ; 10700 bren rd., west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4036398
• MDR Text Key: 4849251
• Report Number: 2183959-2014-45546
• Device Sequence Number: 1
• Product Code: OTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/18/2014

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2011
• Device Catalogue Number: 720191-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2014
• Initial Date FDA Received: 08/15/2014
• 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): Death