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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

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BOSTON SCIENTIFIC CORPORATION ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Migration (4003)
Patient Problems Pain (1994); Prolapse (2475); Blood Loss (2597)
Event Date 08/13/2014
Event Type  Injury  
Event Description

I was diagnosed with central sensitivity syndrome, including fibromyalgia and chronic fatigue syndrome that i believe is directly related to the device. The device has penetrated the vaginal wall ad causes pain and bleeding. Vaginal prolapse is now at 50%. There is only one dr in (b)(6) qualified to remove the device in its entirety and he is located in (b)(6). I am currently trying to get an appt. Other (b)(6) drs are not comfortable removing the entire device, nor are they qualified. My health has been failing since the device was placed during a hysterectomy on (b)(6) 2007 at (b)(6) clinic). Fda safety report id# (b)(4).

 
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Brand NameADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM
Type of DeviceMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key8541164
MDR Text Key142944074
Report NumberMW5086067
Device Sequence Number1
Product Code FTL
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
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/22/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/22/2019 Patient Sequence Number: 1
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