MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Death (1802); Incontinence (1928); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Pain (1994); Scarring (2061); Urinary Frequency (2275); Dysuria (2684)

Event Date 07/22/2008

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated august 30, 2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, erosion, infection, bowel problems, dyspareunia, neuromuscular problems, emotional distress and a product problem.The plaintiff also experienced urinary urge incontinence, stress urinary incontinence, and difficulty emptying the bladder, urinary urgency, dysuria, bladder scar, urinary problems, hesitancy and difficulty starting her stream.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to mfr # 2183959-2016-00024.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5360446
• MDR Text Key: 35670625
• Report Number: 2183959-2016-00025
• Device Sequence Number: 1
• Product Code: PAH
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/13/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/04/2016
• 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
• Treatment: MONARC
• Patient Outcome(s): Death
• Patient Age: 62 YR