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U.S. Department of Health and Human Services

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

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COLOPLAST A/S RESTORELLE TRANSVAGINAL- UNKNOWN SURGICAL MESH Back to Search Results
Lot Number 11031B-01
Device Problem Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Incontinence (1928); Pain (1994); Deformity/ Disfigurement (2360); Prolapse (2475); No Code Available (3191)
Event Date 11/13/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Restorelle trasvaginal known - supplier lot # provided (not coloplast lot #). 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, recurrence of pelvic organ prolapse, dyspareunia, adhesions, exposed mesh. Also stated vaginal prolapse, urinary incontinence, physical deformity and the loss of the ability to perform sexually. Portion of mesh excised and removed.

 
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Brand NameRESTORELLE TRANSVAGINAL- UNKNOWN
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1-3
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 Key10227870
MDR Text Key197791070
Report Number2125050-2020-00510
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 06/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT Number11031B-01
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: 07/03/2020 Patient Sequence Number: 1
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