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

Catalog Number BRD705SI

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/02/2015

Event Type  malfunction  

Event Description

It was reported that the gynecologist had placed the device under conscious sedation without problems.After having the patient cough, which is used during conscious sedation to provide pressure for fixation, the left side turned out to be loose.After inspection of the anchor, it was noted that the tip had broken off.The surgeon could not find the tip, so it was left inside the patient.The surgeon cut the right side of the device and placed a new one without any problems.From the right side, the anchor and small part of the mesh is still left behind in patient.

Manufacturer Narrative

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

• Brand Name: ADJUST ADJUSTABLE SINGLE INCISION SLING
• Manufacturer (Section D): BARD SHANNON LMTD.; humacao
• Manufacturer (Section G): BARD SHANNON LTD.; lot #1, rd #3, km 79.7; san geronimo industrial pk.; humacao 0079 1
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4766355
• MDR Text Key: 5797092
• Report Number: 1018233-2015-00139
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/13/2015

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 Catalogue Number: BRD705SI
• Device Lot Number: HUYG0656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2015
• Initial Date FDA Received: 05/08/2015
• 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