MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS INTEPRO Y-MESH; MESH, SURGICAL, POLYMERIC

Catalog Number 72404000

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Injury (2348); Cancer (3262)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff allegedly experienced an unspecified injury and a product problem.Furthermore, it was reported that the plaintiff died.The cause of death was reported as uterine cancer.

• Brand Name: AMS INTEPRO Y-MESH
• Type of Device: MESH, SURGICAL, POLYMERIC
• 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: 5262082
• MDR Text Key: 32563480
• Report Number: 2183959-2015-00558
• 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: 06/21/2013

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: 12/17/2009
• Device Catalogue Number: 72404000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2015
• Initial Date FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2009
• 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: ADVANTAGE FIT
• Patient Outcome(s): Death