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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC SUPRIS SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE RETRO

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COLOPLAST MANUFACTURING US, LLC SUPRIS SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE RETRO Back to Search Results
Model Number 934450
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fatigue (1849); Swelling (2091); Obstruction/Occlusion (2422)
Event Date 09/15/2017
Event Type  Injury  
Event Description
I seek help for stress urinary incontinence, was told they will put in a sling.No explanation, no previous history asked, nothing else was offered.Next thing when complications start, i had to find out was a tvt mesh sing, this has made me a sick person which i never was, from one problem led to the other; total bladder outlet obstruction.Cystitis are on permanently self catheterization.Loss of sexual intercourse.We in (b)(6) do not have the experienced drs to remove these kind of meshes.We are in desperate need of help.Have no energy left, totally drained out battling with bladder reflux because of the obstruction, medical insurance has been exhausted.
 
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Brand Name
SUPRIS SLING
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE RETRO
Manufacturer (Section D)
COLOPLAST MANUFACTURING US, LLC
MDR Report Key8019361
MDR Text Key125746907
Report NumberMW5080925
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
Reporter Country CodeSF
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/25/2018
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? Yes
Device Operator Health Professional
Device Model Number934450
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/29/2018
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age53 YR
Patient Weight58
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