MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE; SURGICAL MESH

Catalog Number 72404089

Device Problem Insufficient Information (3190)

Patient Problems Adhesion(s) (1695); Erosion (1750); Death (1802); Emotional Changes (1831); Incontinence (1928); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Burning Sensation (2146); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); Hematuria (2558); Cancer (3262)

Event Date 07/31/2007

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced emotional distress and a product problem.Furthermore, the plaintiff also experienced recurrent vaginal prolapse, abdominal and bowel adhesions, urinary retention, vaginal atrophy, dyspareunia, discomfort, erosion, urinary incontinence, burning sensation on bowel movement, pelvic, rectal, abdominal, vaginal pain, urinary frequency, urinary tract infection, vaginal discharge and hematuria.The device was partially explanted.Furthermore, it was reported that the plaintiff died.The cause of death reported was acute myeloid leukemia.Related to mfr# 2183959-2015-00578, 2183959-2015-00579, 2183959-2015-00580.

• Brand Name: AMS APOGEE SYSTEM WITH PC COATED INTEPRO LITE
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS (MN); 10700 bren road w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 5295626
• MDR Text Key: 33464671
• Report Number: 2183959-2015-00577
• 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: 05/08/2013

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: 04/04/2008
• Device Catalogue Number: 72404089
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2007
• 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
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 46