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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; URETHERAL BULKING AGENT

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UROPLASTY, LLC MACROPLASTIQUE IMPLANTS; URETHERAL BULKING AGENT Back to Search Results
Model Number MPQ-2.5
Device Problem Device Operational Issue (2914)
Patient Problems Erosion (1750); Incontinence (1928); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Information was found during a routine literature search as an abstract.Uroplasty has been in contact with one of the abstract's authors, however no additional information has been provided to us at this time.
 
Event Description
A (b)(6) year old male with mild persistent stress urinary incontinence (sui) after a radical prostatectomy underwent elective intraureteral bulking agent injections.After the initial mild improvement, the sui progressed and the patient required 5 diapers a day.The patient subsequently had an artificial urinary sphincter (aus) placement with improvement of his leakage.Two years later, the patient represented with worsening sui despite normal aus function.Upon urethroscopy, it was discovered that the patient had urethral erosion with crystals that enveloped his cuff.These were found to be macroplastique type crystals during pathologic evaluation.Three additional procedures, including aus removal, open and endoscopic procedures were required to remove residual macroplastique crystals.
 
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Brand Name
MACROPLASTIQUE IMPLANTS
Type of Device
URETHERAL BULKING AGENT
Manufacturer (Section D)
UROPLASTY, LLC
5420 feltl road
minnetonka MN 55343
Manufacturer (Section G)
UROPLASTY, LLC
5420 feltl road
minnetonka MN 55343
Manufacturer Contact
nicole boser
5420 feltl road
minnetonka, MN 55343
9524266141
MDR Report Key7650146
MDR Text Key112721690
Report Number3002647932-2018-00006
Device Sequence Number1
Product Code LNM
UDI-Device Identifier08717591240266
UDI-Public08717591240266
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial
Report Date 06/27/2018
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? No
Device Operator No Information
Device Model NumberMPQ-2.5
Device Catalogue NumberMPQ-2.5
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/12/2018
Initial Date FDA Received06/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age67 YR
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