MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MONARC+ SUBFASCIAL HAMMOCK; MESH, SURGICAL, POLYMERIC

Catalog Number 72404193

Device Problem Extrusion (2934)

Patient Problems Death (1802); Emotional Changes (1831); Micturition Urgency (1871); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Urinary Retention (2119); Urinary Frequency (2275); Obstruction/Occlusion (2422); Prolapse (2475); Dysuria (2684)

Event Date 09/16/2013

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 08/30/2014 under (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, extrusion, infection, urinary problems, bowel problems, dyspareunia, neuromuscular problems, emotional distress and a product problem.It was also reported that the plaintiff experienced stage 3 vaginal vault prolapse, urinary retention, polyuria, frequency urination, dysuria, urgency, incomplete bladder emptying, urethral hypermobility and bladder neck obstruction.Additionally, the plaintiff underwent a revision surgery.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The cause of death was reported as blunt force trauma to head and upper body.Related to manufacturer report #: 3011770902-2016-00339.

• Brand Name: AMS MONARC+ SUBFASCIAL HAMMOCK
• 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: randy hoyt ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5840910
• MDR Text Key: 50957809
• Report Number: 3011770902-2016-00335
• 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: 04/24/2013

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: 10/30/2009
• Device Catalogue Number: 72404193
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2008
• 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: PERIGEE
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Weight: 79