MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 720046-01

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Death (1802); Diarrhea (1811); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Tract Infection (2120); Vomiting (2144); Cramp(s) (2193); Urinary Frequency (2275); Hematuria (2558); Dysuria (2684); Constipation (3274)

Event Date 04/08/2009

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced pelvic cramping, mixed incontinence, hematuria, nocturia, enuresis, adhesions, atrophic vaginitis, post void dribbling, recurrent urinary tract infection, episodic constipation, diarrhea, fecal incontinence, dry vaginal mucosa, frequency, dysuria, enlarged pelvic lymph node, worsening, tender on anterior vaginal wall, and vaginal pressure.It was also reported that the plaintiff allegedly experienced pain, infection, urinary problems, dyspareunia, erosion and a product problem.The device remains implanted.Furthermore, it was reported that the plaintiff died.No cause of death was reported.

• Brand Name: AMS MINIARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5604707
• MDR Text Key: 43517522
• Report Number: 3011770902-2016-00189
• 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: 02/09/2013

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: 01/06/2012
• Device Catalogue Number: 720046-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 04/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2009
• 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
• Patient Age: 39 YR
• Patient Weight: 113