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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS INC. SPARC TRANSVAGINAL MESH, SPARC SLING SYSTEM WITH TENSIONING SUTURE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE RETROP
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AMERICAN MEDICAL SYSTEMS INC. SPARC TRANSVAGINAL MESH, SPARC SLING SYSTEM WITH TENSIONING SUTURE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE RETROP Back to Search Results
Catalog Number 72403656
Device Problem Material Erosion (1214)
Patient Problems Failure of Implant (1924); Skin Erosion (2075); Blood Loss (2597)
Event Date 09/10/2002
Event Type  Injury  
Event Description
Retropubic ureteral suspension for sui.After several years, noticed what i thought was a suture in vaginal canal.After seeing gynecologist, she confirmed it was erosion of vaginal mesh into the vaginal canal.Ultrasound performed to see if add'l erosion had taken place into bladder - negative.Erosion is only into vaginal canal.Repeat appt in may to determine need for surgery to remove mesh or clip it back.Symptoms included intermittent vaginal bleeding, post menopause over several years, requiring several vaginal ultrasounds.
 
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Brand Name
SPARC TRANSVAGINAL MESH, SPARC SLING SYSTEM WITH TENSIONING SUTURE
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC FOR STRESS URINARY INCONTINENCE RETROP
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS INC.
MDR Report Key8565186
MDR Text Key143673752
Report NumberMW5086264
Device Sequence Number1
Product Code OTN
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number72403656
Device Lot Number354732001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age66 YR
Patient Weight96
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