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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH

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COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
Model Number 5014501400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Discomfort (2330); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report. Not returned to manufacturer.

 
Event Description

As reported to coloplast, though not verified, patient's legal representative stated vaginal discharge with odor, cystocele, pelvic discomfort, urinary urgency, frequency, dyspareunia, cystocele, vaginal discomfort, second degree cystocele, posterior lesion in the anterior fourchette.

 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key5841268
MDR Text Key50975162
Report Number2125050-2016-00100
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial
Report Date 08/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/02/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5014501400
Device Catalogue Number5014501400
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2016
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/02/2016 Patient Sequence Number: 1
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