MAUDE Adverse Event Report: MACROPLASTIQUE INJECTION; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Urinary Retention (2119); Discomfort (2330)

Event Date 06/12/2018

Event Type  Injury  

Event Description

I had surgery to remove a tumor on my urethra.The doctor did a macroplastique injection and botox injection along with it because he said it would be easier while i was under anesthesia.He told me i would stop having incontinence episodes and having to urinate frequently as a result.Approximately 3 days after the surgery, i awoke with horrible spasms in my abdomen.I could not urinate and had to be catheterized.The spasms continue to this day along with pain and discomfort that prevents me from sitting unless deep cushions are used.I have the urge to urinate almost constantly.The doctor provided no help or relief from these symptoms.I have been to 2 other doctors to try and get some help.They say there is nothing they can do for me so i am left in constant pain and having to urinate almost constantly.I get hardly any sleep.I am losing hope about ever getting any relief from these health issues.Fda safety report id# (b)(4).

• Brand Name: MACROPLASTIQUE INJECTION
• Type of Device: AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
• MDR Report Key: 10343962
• MDR Text Key: 201203048
• Report Number: MW5095808
• 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: 07/27/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 69 YR
• Patient Weight: 68