MAUDE Adverse Event Report: BOSTON SCIENTIFIC UPHOLD LITE; MESH

Model Number 831-817

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

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

Event Date 02/03/2015

Event Type  malfunction  

Event Description

Per dr, the vaginal support system (uphold lite with capio slim ref# (b)(4) lot ml00002420 exp 2017-06) "severed the ethibond suture on the third time." per dr, only half of the sling was attached.

• Brand Name: UPHOLD LITE
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA
• MDR Report Key: 4541583
• MDR Text Key: 5506434
• Report Number: MW5040870
• Device Sequence Number: 1
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2015

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: 06/01/2017
• Device Model Number: 831-817
• Device Catalogue Number: 831-817
• Device Lot Number: ML00002420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR