MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. MONARC SUBFASCIAL HAMMOCK; MESH, SURGICAL, POLYMERIC

Catalog Number 72403830

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Perforation (2001); Blood Loss (2597)

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, infection, urinary problems, bowel problems, bleeding, organ perforation, emotional distress and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death was reported as opiate toxicity.

Manufacturer Narrative

This was initially reported on the summary report dated june 30, 2014 under exemption (b)(4).Lawyer-filed report.

• Brand Name: MONARC SUBFASCIAL HAMMOCK
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, director ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4459557
• MDR Text Key: 17225483
• Report Number: 2183959-2014-25193
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051530
• 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: 02/28/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/14/2014
• Device Catalogue Number: 72403830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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