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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE DIRECTFIX ANT SURGICAL MESH Back to Search Results
Model Number 5014501400
Device Problem Material Erosion (1214)
Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Abnormal Vaginal Discharge (2123)
Event Date 11/05/2015
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, patient's legal representative stated extensive mesh and sling erosion involving the entire anterior vagina with reported previous attempts to remove mesh in office, ongoing vaginal bleeding, discharge, foul odor, pain with intercourse for claimant and partner, vaginal sling takedown, extensive excision of eroded vaginal mesh and cystoscopy under general anesthesia. (b)(4).

 
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Brand NameRESTORELLE DIRECTFIX ANT
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 Key6373538
MDR Text Key68962830
Report Number2125050-2017-00042
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 03/02/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number5014501400
Device Catalogue Number5014501400
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/02/2017 Patient Sequence Number: 1
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