• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COLOPLAST A/S RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH Back to Search Results
Model Number 5014502400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Nerve Damage (1979); Pain (1994); Abnormal Vaginal Discharge (2123); Deformity/ Disfigurement (2360); Prolapse (2475); Dyspareunia (4505); Genital Bleeding (4507); Sexual Dysfunction (4510); Skin Inflammation/ Irritation (4545); Urinary Incontinence (4572); Swelling/ Edema (4577)
Event Type  Injury  
Manufacturer Narrative
Lot number: 5449852. Should additional information prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted. 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 patient experienced severe pain with daily activities and intercourse, multiple severe and painful injures including urinary incontinence, physical deformity and the loss of the ability to perform sexually. The patient had undergone extensive medical treatment including, but not limited to, 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, spine, and vagina, and operations to remove portions of the female genitalia. Additional information received reported that between (b)(6) 2018 and (b)(6) 2019, the patient had experienced or was experiencing mesh extrusion in the upper vagina, enterocele, cystocele, spotting, bleeding, discharge, odor, irritation, swollen labia, and mesh exposed at cuff 3x1 centimeter. The patient underwent removal of the extruded mesh and re-suturing under general anesthesia. Vaginally eroded mesh and postmenopausal bleeding were noted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESTORELLE DIRECTFIX ANTERIOR
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
COLOPLAST A/S
holtedam 1
humlebæk 3050
DA 3050
Manufacturer (Section G)
COLOPLAST MANUFACTURING US, LLC
1601 west river road north
minneapolis MN 55411
Manufacturer Contact
usaby angela kilian
1601 west river road north
minneapolis, MN 55411
8007880293
MDR Report Key12832587
MDR Text Key283487869
Report Number2125050-2021-01660
Device Sequence Number1
Product Code FTL
UDI-Device Identifier05708932484022
UDI-Public05708932484022
Combination Product (y/n)N
PMA/PMN Number
K103568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number5014502400
Device Catalogue Number501450
Was Device Available for Evaluation? No
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/17/2021 Patient Sequence Number: 1
-
-