MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS PERIGEE SYSTEM WITH INTEPRO; SURGICAL MESH

Catalog Number 720003-01

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Pain (1994); Scarring (2061); Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Sleep Dysfunction (2517); Hematuria (2558); Constipation (3274)

Event Date 10/14/2008

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced urinary tract infection, pelvic discomfort, chronic groin pain, nocturia, urinary frequency, decreased urinary flow, moderate cystocele, hypertonic bladder and a questionable urethra dysfunction.The plaintiff also allegedly experienced neuromuscular problem, vaginal scarring, incomplete empting of the bladder, urinary retention, hematuria, dyspareunia, rectocele, mild vaginal atrophy, constipation and vaginal vault prolapse.The plaintiff underwent mesh excision.The mesh was partially explanted.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00342.

• Brand Name: AMS PERIGEE SYSTEM WITH INTEPRO
• Type of Device: SURGICAL MESH
• 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: 5897082
• MDR Text Key: 52789228
• Report Number: 3011770902-2016-00343
• Device Sequence Number: 1
• Product Code: OTP
• 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: 12/04/2012

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: 05/08/2011
• Device Catalogue Number: 720003-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2016
• Initial Date FDA Received: 08/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2008
• 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: MONARC
• Patient Outcome(s): Death
• Patient Age: 68 YR
• Patient Weight: 70