MAUDE Adverse Event Report: BARD SHANNON LIMITED ALIGN URETHRAL SUPPORT SLING

Device Problems Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 04/28/2014

Event Type  malfunction  

Event Description

It was reported that the tyvek tab from an align sling was unable to be located by the physician during a procedure.Current location of the tab is unk and maybe remaining in the pt.Trocar was in place on left side, when pulled up on right side, left side was pulled on and tab and sheath disconnected.Physician stitched sheath to mesh rather than remove trocar from initial side and ran through.Physician chose not to explore further for missing tab.Pt transferred from operating room in stable condition.

Manufacturer Narrative

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

• Brand Name: ALIGN URETHRAL SUPPORT SLING
• Manufacturer (Section D): BARD SHANNON LIMITED; humacao PR
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo indistrial park; lot #1, road #3, km 97.7; humacao PR 00791
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3876832
• MDR Text Key: 4512081
• Report Number: 1018233-2014-00108
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 04/29/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 46 YR