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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE DIRECTFIX POS SURGICAL MESH Back to Search Results
Model Number 5014601400
Device Problems Device Emits Odor (1425); Device Operates Differently Than Expected (2913)
Patient Problem Abnormal Vaginal Discharge (2123)
Event Date 04/28/2015
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

As reported to coloplast, though not verified, the patient's legal representative stated vaginal mesh exposure at the apex, 0. 5 cm x 0. 5 cm, vaginal discharge with odor, consortium claim.

 
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Brand NameRESTORELLE DIRECTFIX POS
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 Key5981809
MDR Text Key55790237
Report Number2125050-2016-00230
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 09/27/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5014601400
Device Catalogue Number5014601400
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/27/2016 Patient Sequence Number: 1
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