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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE- UNKNOWN SURGICAL MESH

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COLOPLAST A/S RESTORELLE- UNKNOWN SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Emotional Changes (1831); Incontinence (1928); Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Tissue Damage (2104); Discharge (2225); Injury (2348); Deformity/ Disfigurement (2360); No Information (3190); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report. (b)(4).
 
Event Description
As reported to coloplast though not verified, patient's legal representative stated inter alia, severe pain with daily activities and intercourse, severe emotional pain and injury, increased risk for injuries, infections, pain, mental anguish, discharge, and multiple corrective surgeries. Underwent operations to locate and remove mesh, operations to attempt to repair pelvic organs, tissue, and nerve damage, the use of pain control and other medications, injections into various areas of the pelvis, spline and the vagina, and operations to remove portions of the female genitalia. Urinary incontinence, physical deformity and the loss of the ability to perform sexually. It was noted that the plaintiff required surgical revision of the mesh in (b)(6) 2019, and again in (b)(6) 2019.
 
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Brand NameRESTORELLE- UNKNOWN
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
Manufacturer Contact
sarah o'gara
1601 west river road north
minneapolis, mn 
MDR Report Key9942967
MDR Text Key187037716
Report Number2125050-2020-00322
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
Report Date 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2020
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 Received03/09/2020
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: 04/09/2020 Patient Sequence Number: 1
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