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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE DIRECTFIX POSTERIOR SURGICAL MESH Back to Search Results
Model Number 5014602400
Device Problem Positioning Problem (3009)
Patient Problem Urinary Retention (2119)
Event Date 09/06/2016
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

According to the available information, patient experienced urinary retention. Catheter removed from patient on (b)6). She was unable to void. (b)(6): back to operative room for loosening the sling. Unable to void after the procedure. (b)(6), was discharged from hospital to home with catheter.

 
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Brand NameRESTORELLE DIRECTFIX POSTERIOR
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 Key6331558
MDR Text Key67477841
Report Number2125050-2017-00016
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 HEALTH PROFESSIONAL,OTHER,STU
Type of Report Initial
Report Date 02/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/15/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5014602400
Device Catalogue Number5014602400
Device LOT Number4437610
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/06/2017
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: 02/15/2017 Patient Sequence Number: 1
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