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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S UKNOWN FEM PELVIC HEALTH MESH SURGICAL MESH

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COLOPLAST A/S UKNOWN FEM PELVIC HEALTH MESH SURGICAL MESH Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Micturition Urgency (1871); Unspecified Infection (1930); Urinary Retention (2119); Abnormal Vaginal Discharge (2123); Urinary Frequency (2275); Dysuria (2684)
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, patient's legal representative stated retention, frequency, urgency, infection, nocturia, vaginal discharge, and dysuria.

 
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Brand NameUKNOWN FEM PELVIC HEALTH MESH
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, dk 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 Key5939256
MDR Text Key54307976
Report Number2125050-2016-00206
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Type of Report Initial
Report Date 09/06/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2016
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: 09/09/2016 Patient Sequence Number: 1
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