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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S SURGICAL MESH

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COLOPLAST A/S SURGICAL MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

Item # listed in legal claim states 5195612400 which is a supris product. However the legal claim also listed the product name as an aris. It is unknown at this time which product name is correct. (b)(4). 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, the legal representative stated severe pain with daily activities, dyspareunia, recurrence of the pelvic organ prolapse. Stated vaginal prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually. Information indicated the patient also had an exair product, reported under 2125050-2020-00512.

 
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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
stephanie perryman
1601 west river road north
minneapolis, mn 
MDR Report Key10267923
MDR Text Key198630073
Report Number2125050-2020-00551
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 07/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2020
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: 07/13/2020 Patient Sequence Number: 1
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