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

Model Number	5014502400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	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)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2125050-2021-01660
• Device Sequence Number: 11136006
• Product Code: FTL
• UDI-Device Identifier: 05708932484022
• UDI-Public: 05708932484022
• Combination Product (Y/N): N
• PMA/510(K) Number: K103568
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female