Bulkamid 50050 (UDI 05704101500500)Recalls & reported problems
Contura International A/S · Bulkamid Urethral Bulking System · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05704101500500), received between May 26, 2023 and Mar 29, 2024 — classified as 8 injuries, 1 malfunction.
The most frequently reported specific device problem is “Unexpected Therapeutic Results” (4 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Unexpected Therapeutic Results4
- Adverse Event Without Identified Device or Use Problem3
- Malposition of Device1
Patient problems
- Urinary Tract Infection4
- Hematoma2
- Urinary Retention2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Genital Bleeding1
- Hematuria1
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2024
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.
Patient problems: Insufficient Information
MAUDE report 19003051 ↗InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE SECTION H, NUMBER 6 FOR THE INVESTIGATION CONCLUSION CODE UPDATED.
Patient problems: Genital Bleeding; Hematoma; Urinary Retention
MAUDE report 17785204 ↗InjuryAug 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SEE SECTION H, NUMBER 6 FOR THE INVESTIGATION CONCLUSION CODE UPDATED.
Patient problems: Hematuria
MAUDE report 17596938 ↗InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED A MEDICAL INTERVENTION TO TREAT URINARY RETENTION AND HEMATOMA.
Patient problems: Hematoma; Urinary Retention
MAUDE report 17368107 ↗InjuryJun 30, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results
THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR UTI AFTER A BULKAMID PROCEDURE.
Patient problems: Urinary Tract Infection
MAUDE report 17243164 ↗InjuryJun 2, 2023Malposition of Device; Malposition of Device
THE PATIENT UNDERWENT BULKAMID CUSHION EXCISION DUE TO THE MALPOSITION OF THE DEVICE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 17055526 ↗InjuryMay 30, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results
SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.
Patient problems: Urinary Tract Infection
MAUDE report 17021623 ↗InjuryMay 26, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results
SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.
Patient problems: Urinary Tract Infection
MAUDE report 17015106 ↗InjuryMay 26, 2023Unexpected Therapeutic Results; Unexpected Therapeutic Results
SEE SECTION H, NUMBER 6 FOR INVESTIGATION UPDATES.
Patient problems: Urinary Tract Infection
MAUDE report 17015105 ↗
Other Agent, Bulking, Injectable For Gastro-Urology Use devices
- Deflux Gel 1.0 mL SyringePalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use63 reports
- Bulkamid 50050Axonics Modulation Technologies, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use1 death32 reports
- Macroplastique Implants MPQ-2.5Uroplasty, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use12 reports
- Solesta Gel 1.0 mL SyringePalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use6 reports
- Deflux Metal Needle 3.7 FR x 23 G (tip) x 350 mmPalette Life Sciences, Inc. · Agent, Bulking, Injectable For Gastro-Urology Use1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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