MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. UNKNOWN GRAFT; MESH, SURGICAL, POLYMERIC

Device Problem Insufficient Information (3190)

Patient Problems Atherosclerosis (1728); Death (1802); High Blood Pressure/ Hypertension (1908); Scar Tissue (2060); Prolapse (2475)

Event Type  Death  

Manufacturer Narrative

Lawyer-filed report.

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced posterior vaginal wall prolapse, recurrent enterocele, rectocele, and vaginal apical scar.Furthermore, it was reported that the plaintiff died.The cause of death reported were aortic dissection, hypertension, and atherosclerosis.Related to manufacturer report #: 2183959-2015-60255 related to manufacturer report #: 2183959-2015-60254.

• Brand Name: UNKNOWN GRAFT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer (Section G): AMERICAN MEDICAL SYSTEMS, INC.; 10700 bren rd w; minnetonka MN 55343
• Manufacturer Contact: erika merrick ; 10700 bren rd w; minnetonka, MN 55343 ; 8442511068
• MDR Report Key: 5090657
• MDR Text Key: 26265233
• Report Number: 2183959-2015-60135
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Report Date: 09/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: INTEPRO Y-MESH
• Patient Outcome(s): Death