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

Catalog Number 831817

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 09/01/2015

Event Type  malfunction  

Event Description

Doctor attempted to implant the uphold light with capio slim into patient, when before insertion the tip broke off.Same event with 2 separate devices.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5110238
• MDR Text Key: 27020275
• Report Number: 5110238
• Device Sequence Number: 0
• Product Code: OTN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 831817
• Device Lot Number: ML00002635
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR