MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS BIOARC TO WITH PRE-CONNECTED COLLAGEN DERMAL; SURGICAL MESH

Catalog Number 72404087

Device Problem Insufficient Information (3190)

Patient Problems Atherosclerosis (1728); Death (1802); High Blood Pressure/ Hypertension (1908); Injury (2348)

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced an unspecified injury.Furthermore, it was reported that the plaintiff died.The cause of death reported was hypertensive atherosclerotic cardiovascular disease.Related to mfr # 2183959-2015-00586.

• Brand Name: AMS BIOARC TO WITH PRE-CONNECTED COLLAGEN DERMAL
• 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: 5298948
• MDR Text Key: 33550162
• Report Number: 2183959-2015-00587
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• 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: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/09/2013
• Device Catalogue Number: 72404087
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2012
• 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: MONARC
• Patient Outcome(s): Death