MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD; SURGICAL MESH

Model Number M0068318170

Device Problem Positioning Problem (3009)

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

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Boston scientific uphold lite w/ capio slim vaginal support system was used.The bullet did not capture during use requiring an additional capio device to be opened.

• Brand Name: UPHOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 4252972
• MDR Text Key: 5016056
• Report Number: 4252972
• Device Sequence Number: 1
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2014

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: Physician
• Device Model Number: M0068318170
• Device Lot Number: ML00002471
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2014
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 68 YR
• Patient Weight: 61