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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (2BO)RESTORELLE DIRECTFIX POS SURGICAL MESH

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COLOPLAST A/S (2BO)RESTORELLE DIRECTFIX POS SURGICAL MESH Back to Search Results
Model Number 5014601400
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Abnormal Vaginal Discharge (2123)
Event Date 10/11/2016
Event Type  Injury  
Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence, should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

 
Event Description

As reported to coloplast, though not verified, subject experienced purulent vaginal discharge on (b)(6) 2016 resulting in inpatient hospitalization and surgical procedure on (b)(6) 2016. During procedure, the restorelle df posterior device was partially explanted at the posterior vaginal wall and apex.

 
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Brand Name(2BO)RESTORELLE 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 Key6025957
MDR Text Key57296066
Report Number2125050-2016-00297
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 10/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/13/2016
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 Received10/12/2016
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: 10/13/2016 Patient Sequence Number: 1
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