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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE (TRANSVAGINAL) SURGICAL MESH

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COLOPLAST A/S RESTORELLE (TRANSVAGINAL) SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Pain (1994); Injury (2348); No Information (3190)
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 plaintiff has suffered severe pain with daily activities and intercourse. Plaintiff continues to suffer, multiple, severe and painful personal injuries, including, but not limited to, urinary incontinence, physical deformity, and the loss of the ability to perform sexually.
 
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Brand NameRESTORELLE (TRANSVAGINAL)
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebaek, 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
stephanie perryman
1601 west river road north
minneapolis, MN 55411
6124345685
MDR Report Key9336445
MDR Text Key166819441
Report Number2125050-2019-00965
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 other
Type of Report Initial,Followup
Report Date 12/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
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 Received10/23/2019
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: 11/18/2019 Patient Sequence Number: 1
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