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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COGENTIX MEDICAL / UROPLASTY, LLC MACROPLASTIQUE IMPLANT; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
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COGENTIX MEDICAL / UROPLASTY, LLC MACROPLASTIQUE IMPLANT; AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE Back to Search Results
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Incontinence (1928)
Event Date 01/01/2019
Event Type  Injury  
Event Description
Migration of implant was discovered; (b)(6) 2005 - dr (b)(6) of (b)(6), inserted two macroplastique implants in my urethral.On (b)(6) 2019 unrelated ct performed, a mass was found in my bladder at the urethral neck.(b)(6).On (b)(6) 2019 - cystoscopy done of bladder by urologist dr (b)(6), in (b)(6).Mass of calcium crystals found attached to exposed macroplastique implant in bladder at urethra neck.On (b)(6) 2019 - laser lithoplasty removed calcium growth by dr (b)(6).One month later it was found to be growing back.Mri with and without contrast done (b)(6) 2020 - dr (b)(6) of (b)(6), performed surgery (robot assisted) to remove implant, calcium and eroded bladder wall.On june 1, 2020 currently i am incontinent, waiting for mid - urethral sling procedure, summer of 2020.
 
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Brand Name
MACROPLASTIQUE IMPLANT
Type of Device
AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
Manufacturer (Section D)
COGENTIX MEDICAL / UROPLASTY, LLC
MDR Report Key10173754
MDR Text Key195974166
Report NumberMW5095074
Device Sequence Number1
Product Code LNM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
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? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2020
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Treatment
ASPIRIN ; ATROVENT; BENEFIBER ; BITALIN ; BORON; CALCIUM; CELEBREX ; CENTRUM SILVER ; CLONAZEPAM ; COQ-10; CRESTOR ; CYMBALTA; FAMOTIDINE ; FISH OIL ; FLONASE; GEODON ; GUAITENESIN ; JANUVIA; LYCOPENE; METFORMIN ; MIRALAX; MOTEGRITY; PANTOPRAZOLE ; PROVIGIL; SELENIUM; VIT B; XOPENEX
Patient Outcome(s) Hospitalization; Other; Required Intervention; Disability;
Patient Age66 YR
Patient Weight59
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