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

Model Number 50050

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 04/01/2021

Event Type  Injury  

Event Description

The company was made aware on 06/05/2021 that the physician performed a needle aspiration and incision to drain an abscess.No infection was detected.

Event Description

See section h, number 6 for investigation updates.

• Brand Name: BULKAMID URETHRAL BULKING SYSTEM
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): CONTURA INTERNATIONA A/S; 23 sydmarken; soeborg 2860
• MDR Report Key: 12108303
• MDR Text Key: 259986147
• Report Number: 3002968685-2021-00030
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 50050
• Device Lot Number: 19F0403
• Date Manufacturer Received: 06/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1