BULKAMID
Report
- Report Number
- 2124215-2025-91913
- Event Type
- Injury
- Date Received
- December 18, 2025
- Date of Event
- November 15, 2025
- Report Date
- January 23, 2026
- Manufacturer
- CONTURA INTERNATIONAL A/S
- Product Code
- LNM
- UDI-DI
- 10810005340509
- PMA / PMN Number
- P170023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE E2330 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PAIN. BLOCK H11: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
BLOCKS D4 AND H4: THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK H6: PATIENT CODE E2330 IS BEING USED TO CAPTURE THE REPORTABLE EVENT OF PAIN. BLOCK H11: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. BLOCK B3 WAS UPDATED BASED ON ADDITIONAL INFORMATION.
IT WAS REPORTED THAT A BULKAMID PROCEDURE WAS PERFORMED ON (B)(6) 2025, WITHOUT COMPLICATIONS. HOWEVER, IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BURNING AND PAIN SENSATION DURING URINATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS RELEASED. THE PATIENT DID COMPLAIN THAT THIS WAS AN ISSUE BEFORE HER PROCEDURE.
IT WAS REPORTED THAT A BULKAMID PROCEDURE WAS PERFORMED ON (B)(6) 2025, WITHOUT COMPLICATIONS. HOWEVER, IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO BURNING AND PAIN SENSATION DURING URINATION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND WAS RELEASED. THE PATIENT DID COMPLAIN THAT THIS WAS AN ISSUE BEFORE HER PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 260070 | BULKAMID | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE | LNM | CONTURA INTERNATIONAL A/S | 50050 | 10810005340509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |