MAUDE Adverse Event Report: CONTURA INTERNATIONAL A/S BULKAMID; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Model Number 50050

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  malfunction  

Event Description

Surgeon was attempting to inject bulkamid into the patient, the sheath was not functioning properly so the bulking agent was not able to be injected.The or nurse had to open a second bulkamid kit in order to open a new sheath.The new sheath functioned properly and the bulking agent was able to be properly injected.The representative from bulkamid was contacted and made aware of the situation.

• Brand Name: BULKAMID
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): CONTURA INTERNATIONAL A/S; 26 technology drive; irvine CA 92618
• MDR Report Key: 19003051
• MDR Text Key: 338895435
• Report Number: 19003051
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 05704101500500
• UDI-Public: (01)05704101500500
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2024

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 Model Number: 50050
• Device Lot Number: 23F1402AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/24/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 77 KG
• Patient Race: White