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

Model Number	50050
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): CONTURA INTERNATIONAL A/S; 26 technology drive; irvine CA 92618
• MDR Report Key: 19003051
• Report Number: 19003051
• Device Sequence Number: 13104559
• Product Code: LNM
• UDI-Device Identifier: 05704101500500
• UDI-Public: (01)05704101500500
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2024
• Report Date (Section F): 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
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Unknown
• Patient Weight: 77 KG
• Patient Race: White
• Date Report Sent to FDA: 01/24/2024