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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECT FIX P 1; SURGICAL MESH
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COLOPLAST A/S RESTORELLE DIRECT FIX P 1; SURGICAL MESH Back to Search Results
Model Number 5013801400
Device Problems Device Operates Differently Than Expected (2913); Material Protrusion/Extrusion (2979)
Patient Problems Prolapse (2475); Dysuria (2684)
Event Date 11/15/2010
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 claimant reported change in voiding, difficulty starting flow, anterior prolapse noted, bulge and protrusion at introitus noted, with anterior apical failure of repair, anterior defect noted, worsening bladder prolapse reported.(b)(4).
 
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Brand Name
RESTORELLE DIRECT FIX P 1
Type of Device
SURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, da 3050
DA  3050
Manufacturer Contact
christine buckvold
1601 west river road north
minneapolis, MN 55411
6123024982
MDR Report Key6331576
MDR Text Key67479750
Report Number2125050-2017-00018
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
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 No Information
Device Model Number5013801400
Device Catalogue Number5013801400
Was Device Available for Evaluation? No
Date Manufacturer Received11/15/2010
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 N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
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