MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 9000056

Device Problem Extrusion (2934)

Patient Problem Tissue Damage (2104)

Event Date 03/10/2014

Event Type  Injury  

Event Description

It was reported the patient post operatively experienced a "midline, 1x1 extrusion." the mesh was palpable and her husband had pain with intercourse.There was "no bladder injury." the physician "excised that portion of the mesh and did a partial closure of the vaginal opening.The patient is doing fine now." the excised portion of mesh was sent to the hospital's pathology department.No further patient complications were reported in relation to this event.

Manufacturer Narrative

(b)(4).Analysis results: the partial miniarc precise sling was visually inspected.The sling piece is approximately 1 cm x 1 cm.The sling piece appears to have been cut on all four sides.The mesh material appears normal.No conclusion can be drawn.

• Brand Name: AMS MONARC SLING SYSTEM
• 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 (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: sharon zurn ; 10700 bren road w; minnetonka, MN 55343 ; 9529306000
• MDR Report Key: 3702208
• MDR Text Key: 4339202
• Report Number: 2183959-2014-00096
• Device Sequence Number: 1
• Product Code: OTN
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/26/2016
• Device Catalogue Number: 9000056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2013
• 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): Hospitalization; Required Intervention
• Patient Age: 38 YR