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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S (MPO)RESTORELLE DIRECTFIX POST SURGICAL MESH

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COLOPLAST A/S (MPO)RESTORELLE DIRECTFIX POST SURGICAL MESH Back to Search Results
Model Number 5014602400
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Incontinence (1928); Pain (1994)
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 severe pain with daily activities and intercourse, incontinence, bowel problems and erosion.
 
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Brand Name(MPO)RESTORELLE DIRECTFIX POST
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west rivier road north
minneapolis MN 55411
Manufacturer Contact
sarah o'gara
1601 west rivier road north
minneapolis, MN 55411
6123578517
MDR Report Key8641932
MDR Text Key146112446
Report Number2125050-2019-00413
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 other
Type of Report Initial
Report Date 05/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014602400
Device Catalogue Number501460
Device Lot Number2936642
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2019
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 Unkown

Patient Treatment Data
Date Received: 05/24/2019 Patient Sequence Number: 1
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