MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS PERIGEE SYSTEM WITH INTEPRO; MESH, SURGICAL, FOLEYMERIC

Catalog Number 72404210

Device Problem Extrusion (2934)

Patient Problems Erosion (1750); Death (1802); Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Injury (2348); Deformity/ Disfigurement (2360); Intermenstrual Bleeding (2665)

Event Date 09/26/2008

Event Type  Death  

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, erosion, suffering, mental anguish, disfigurement, physical impairment, infection, urinary and bowel problems, bleeding, vaginal scarring, emotional distress, product problem and other unspecified injury.The plaintiff also experience vaginal mesh extrusion.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to mfr report # 2183959-2014-14025, -54619.

Manufacturer Narrative

This was initially reported on the summary report dated (b)(6) 2014 under exemption (b)(4).Additionally this was reported on the summary report dated (b)(6) 2015 under exemption (b)(4).Lawyer-filed report.

• Brand Name: AMS PERIGEE SYSTEM WITH INTEPRO
• Type of Device: MESH, SURGICAL, FOLEYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren road west; minnetonka MN 55343
• Manufacturer Contact: sharon zurn, dir ; 10700 bren road west; minnetonka, MN 55343 ; 9529306347
• MDR Report Key: 4897914
• MDR Text Key: 6073012
• Report Number: 2183959-2014-14692
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/12/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2008
• Device Catalogue Number: 72404210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2007
• 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: APOGEE; MONARC
• Patient Outcome(s): Death
• Patient Age: 55 YR
• Patient Weight: 63