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

Model Number 50050

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Abdominal Pain (1685)

Event Date 06/24/2021

Event Type  Injury  

Event Description

The company was made aware on (b)(6) 2021 that the patient had pain and erosion of bulkamid in the bladder that resulted in catheterization.

Event Description

See section h6 for updates.

Event Description

There have been no updates on this case to date, awaiting physician's response.

• 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
• Manufacturer (Section G): CONTURA INTERNATIONA A/S; 23 sydmarken; soeborg 2860
• Manufacturer Contact: malti desai ; 26 technology drive; irvine, CA
• MDR Report Key: 12704662
• MDR Text Key: 278585184
• Report Number: 3002968685-2021-00048
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 19F0704AA
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1