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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 5014502400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Chills (2191); No Code Available (3191)
Event Date 01/21/2017
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, ae event 1: urinary tract infection (uti), lower. Fever, chills, left cva tenderness since (b)(6) 2017. Subject was hospitalized. (b)(6) 2017 - uti and post op infection resolved. Ae event 2: exam under anesthesia vaginal purulent material discharge. Subject was hospitalized. Subject also underwent inpatient surgical intervention for incision and drainage of posterior repair. (b)(6) 2017 - infection resolved.

 
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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 Key6331546
MDR Text Key67476800
Report Number2125050-2017-00014
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 Number5014502400
Device Catalogue Number5014502400
Device LOT Number5200337
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2017
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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