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

Catalog Number BRD705SI

Device Problems Break (1069); Disconnection (1171); Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2014

Event Type  malfunction  

Event Description

It was reported that when the doctor opened the package the fixed anchor was found to be disconnected.Upon return of the sample it was found that the mesh had been sectioned and the post of the adjustable anchor was broken.The mesh was bloody and appeared to be used.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found no manufacturing related issues that would have caused or contributed to the reported event.

• Brand Name: ADJUST ADJUSTABLE SINGLE INCISION SLING
• Manufacturer (Section D): BARD SHANNON LIMITED; humacao PR
• Manufacturer (Section G): BARD SHANNON LIMITED; lot #1, road #3, km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4534663
• MDR Text Key: 5516231
• Report Number: 1018233-2015-00044
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2015

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: 05/31/2016
• Device Catalogue Number: BRD705SI
• Device Lot Number: HUYE0526
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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