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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST MANUFACTURING US, LLC RESTORELLE Y MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
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COLOPLAST MANUFACTURING US, LLC RESTORELLE Y MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP Back to Search Results
Catalog Number 501420
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Pain (1994); Rash (2033); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Fungal Infection (2419)
Event Date 02/04/2020
Event Type  Injury  
Event Description
I was implanted with mesh for a pelvic prolapse on (b)(6) 2020, it was sacrocolpopexy mesh and a sub urethral sling.About 7 weeks post op i had lots of vaginal discharge, uti symptoms, yeast infections, rashes, pain at the urethra, deep vaginal pain, painful intercourse, change in bowel habits, urinate urgency, frequency, retention.I then had a total removal on (b)(6) 2020.I traveled 30 hours away from my home state for this removal.Fda safety report id# (b)(4).
 
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Brand Name
RESTORELLE Y MESH
Type of Device
MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
Manufacturer (Section D)
COLOPLAST MANUFACTURING US, LLC
MDR Report Key10301477
MDR Text Key199873988
Report NumberMW5095617
Device Sequence Number1
Product Code OTO
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
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date04/11/2022
Device Catalogue Number501420
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention; Disability;
Patient Age125 YR
Patient Weight57
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