MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MONARC+ SUBFASCIAL HAMMOCK; MESH, SURGICAL, POLYMERIC

Catalog Number 72404193

Device Problem Insufficient Information (3190)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Total number of events summarized - (b)(4).Ams bio arc pre-connected collagen dermal - (b)(4).Ams bio arc sling system - (b)(4).Ams monarc c-sling system - (b)(4).Ams monarc sling system - (b)(4).Ams monarc+ subfascial hammock - (b)(4).Ams sparc sling system - (b)(4).Unknown sling system - (b)(4).

Event Description

It was reported by the plaintiff's attorney that the plaintiff experienced an unspecified injury.The device remains implanted.No further complications have been reported in relation to this event.

• Brand Name: AMS MONARC+ SUBFASCIAL HAMMOCK
• 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: 5146726
• MDR Text Key: 28136993
• Report Number: 2183959-2015-57066
• 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: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/28/2008
• Device Catalogue Number: 72404193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2007
• 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): Disability