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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH

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COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
Model Number 5014502400
Device Problem Insufficient Information (3190)
Patient Problems Incontinence (1928); Pain (1994); Cramp(s) (2193); Prolapse (2475); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(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, patient's legal representative stated that within six weeks following surgery, the patient began experiencing symptoms indicative of complications from the implanted transvaginal mesh. Specifically: pelvic pain, pain during sexual intercourse, protrusion due to prolapse, physical sensation of prolapse, reoccurrence of incontinence, bulging sensation in her vaginal canal as constant, urine leakage with coughing, sneezing, or pressure, cramping with a pinching sensation in the pelvic floor region.

 
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Brand NameRESTORELLE DIRECTFIX ANTERIOR
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
lauren prioleau
1601 west river road north
minneapolis, mn 
MDR Report Key10381854
MDR Text Key202208183
Report Number2125050-2020-00619
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Type of Report Initial
Report Date 08/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number5014502400
Device Catalogue Number501450
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
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: 08/07/2020 Patient Sequence Number: 1
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