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

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.

• Brand Name: RESTORELLE DIRECTFIX ANTERIOR
• Type of Device: SURGICAL 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 Key: 12832587
• MDR Text Key: 283487869
• Report Number: 2125050-2021-01660
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (y/n): N
• PMA/PMN Number: K103568
• Number of Events Reported: 1
• 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 Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female