MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number 72403831

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An opened tray in the original box was returned.The tray contained two needles with connectors attached.One connector was broken and forceps marks were present on the broken end.The sling was also returned.The sheath had been removed and was not present amongst the returned components.The sling was elongated (necking) at several points along its length.The suture was hanging loose from the sling (while still threaded within the sling).

Event Description

It was reported that during implantation of monarc, "the tape does not slip and was in disrepair." no patient complications reported as a result of this event.If additional information is received, a follow up report will be sent.

• Brand Name: AMS MONARC SLING SYSTEM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ASTORA WOMEN'S HEALTH LLC; 13200 pioneer trail; suite 100; eden prairie MN 55347
• Manufacturer (Section G): ASTORA WOMEN'S HEALTH (IRELAND); athlone business & tech park; garrycastle, dublin road; co. westmeath ; EI
• Manufacturer Contact: erika a. merrick ; 13200 pioneer trail; suite 100; eden prairie, MN 55347 ; 9522383906
• MDR Report Key: 5574612
• MDR Text Key: 42610461
• Report Number: 3011770902-2016-00170
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2017
• Device Catalogue Number: 72403831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2016
• Initial Date Manufacturer Received: 04/06/2016
• Initial Date FDA Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2014
• 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): Required Intervention