MAUDE Adverse Event Report: BARD SHANNON LIMITED ADJUST HELICAL SINGLE INCISION SLING

Catalog Number BRD800SI

Device Problems Malposition of Device (2616); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

It was reported the mesh pulled/tore off the trocar.No patient impact.Procedure was completed with a second device.

Manufacturer Narrative

Investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

• Brand Name: ADJUST HELICAL SINGLE INCISION SLING
• Manufacturer (Section D): BARD SHANNON LIMITED; humacao PR
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot#1, road#3, km 79.7; humacao PR 00791
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4037127
• MDR Text Key: 4724521
• Report Number: 1018233-2014-00211
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/24/2014

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: 10/31/2014
• Device Catalogue Number: BRD800SI
• Device Lot Number: HUXE0628
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2014
• Initial Date FDA Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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