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

Catalog Number 72404210

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Micturition Urgency (1871); Hemorrhage, Subarachnoid (1893); Incontinence (1928); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Sleep Dysfunction (2517); Dysuria (2684); Hydrocephalus (3272)

Event Date 08/13/2007

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2015 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced urinary retention, urgency, nocturia, fecal incontinence, dysuria, urinary tract infection, recurrent cystocele and malpositioned sling.The plaintiff underwent a revision surgery.The mesh was partially explanted.Furthermore, it was reported that the plaintiff died.The causes of death were reported as hydrocephalus and subarachnoid hemorrhage.Related to manufacturer report #: 3011770902-2016-00287, 3011770902-2016-00286.

• 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: 5755757
• MDR Text Key: 48352717
• Report Number: 3011770902-2016-00288
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• 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: 03/19/2015

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: 01/25/2008
• Device Catalogue Number: 72404210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/16/2016
• Initial Date FDA Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2007
• 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: SPARC
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 59