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

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Fatigue (1849); Micturition Urgency (1871); Incontinence (1928); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Hematuria (2558); Blood Loss (2597); Weight Changes (2607); Dysuria (2684)

Event Date 03/30/2011

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced hematuria with isomorphic erythrocytes indicating lower urinary tract infection, uroepithelial bleeding, bacteriuria, abundant squamous epithelium and kenoturia.It was also reported that the plaintiff experienced problems with pelvic pressure, difficulty with intercourse, erosion, urge incontinence, severe vaginal atrophy, excessive fatigue, change in weight, incontinence, urinary frequency, urgency, vaginal discharge, extrusion, leakage, dysuria, amenorrhea, menorrhagia, pelvic pain and other unspecified sexual concerns.Furthermore, the plaintiff underwent revision surgery, however, the mesh remains partially implanted.Furthermore, it was reported that the plaintiff died.No cause of death was reported.

• Brand Name: AMS MONARC 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: 5604706
• MDR Text Key: 43517553
• Report Number: 3011770902-2016-00190
• Device Sequence Number: 1
• Product Code: OTN
• 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: 09/11/2013

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2016
• Initial Date FDA Received: 04/25/2016
• 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
• Patient Outcome(s): Death
• Patient Age: 77 YR