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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problems Urinary Retention (2119); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684); Urinary Incontinence (4572)

Event Date 01/17/2022

Event Type  Injury  

Event Description

I was treated with bulkamid for urinary leakage in (b)(6) 2021.After the procedure, i did have any issues until about 1 mo later and then i started to get utis.I was treated with antibiotics.Now in april i can't empty my bladder all the way and have to urinate all the time.If i get up to walk, i have to go to the bathroom every time.It also burns when i pee although i don't have an uti.I believe the procedure has created new issues beside leakage.I don't know if they put too much in, whether my body is sensitive to the material or whether my prolapse has worsen.Fda safety report id# (b)(4).

• Brand Name: BULKAMID
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• Manufacturer (Section D): CONTURA INTERNATIONAL A/S
• MDR Report Key: 14288441
• MDR Text Key: 290945747
• Report Number: MW5109525
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White