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

Catalog Number 72403656

Device Problems Tear, Rip or Hole in Device Packaging (2385); Extrusion (2934)

Patient Problems Death (1802); Incontinence (1928); Pain (1994); Injury (2348); Prolapse (2475)

Event Date 03/02/2006

Event Type  Death  

Manufacturer Narrative

This was initially reported on the summary report dated 6/30/2014 under exemption (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced urethral hypermobility, mesh exposure, gastrointestinal symptoms, felt rip, feeling of bladder sitting in abdomen, recurrence and stress urinary incontinence.The plaintiff also allegedly experienced pain, urinary problems, dyspareunia and other unspecified injury.The device was partially excised.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00207.

• Brand Name: AMS SPARC 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: 5616818
• MDR Text Key: 43935687
• Report Number: 3011770902-2016-00206
• 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: 12/18/2013

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: 09/13/2006
• Device Catalogue Number: 72403656
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2016
• Initial Date FDA Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2005
• 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: 44 YR
• Patient Weight: 108