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); Pain (1994); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Genital Bleeding (4507)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

According to the available information, the patient's legal representative reported pain, chronic uti, vaginal bleeding, urinary incontinence, vaginal discharge, mesh erosion.Restorelle l was implanted on (b)(6) 2016 and excised on (b)(6) 2016.Corrective action: management routinely reviews events such as this and monitors complaint levels.Additionally, events of this type relating to the reported complaints are captured in the product risk documentation.Based on this, and because the device is not available for evaluation, no further corrective action is required at this time.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Device not returned.

Event Description

As reported to coloplast, though not verified, patient's legal representative reported pain, chronic uti, vaginal bleeding, urinary incontinence, vaginal discharge, mesh erosion.Additional information received on 04/09/2021.Palpable mesh, overactive bladder, cystocele.(b)(6) 2016 - chronic uti after anterior repair.(b)(6) 2016 - eroded mesh.Cystourethroscopy with sounding, pelvic exam, excision of eroded vaginal mesh.Small exposed mesh vs suture, vaginal burning/pain.(b)(6) 2016 - cystourethroscopy with sound pelvic, mesh excision.(b)(6) 2016 - erosion.Laser ablation of eroded mesh and excision with closure of the vaginal mucosa with vaginoscopy and cystoscopy.Abdominal pain, fever, vaginal discharge, positive blood cultures.Exposure, grade 1 rectocele and cystocele, granulation tissue, tender right proximal limb.(b)(6) 2016 - chronic inflammation and necrotic tissue with mesh graft exposure in the left anterior vaginal wall and painful right proximal graft limb with palpable anchor.Excision of necrotic vaginal wall tissue and mesh graft material.Patch graft with a-cell graft and excision of bone anchor.Infected mesh.No other adverse patient effects were reported.

• 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: 12612104
• MDR Text Key: 275925758
• Report Number: 2125050-2021-01469
• 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
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5014502400
• Device Catalogue Number: 501450
• Device Lot Number: 3812401
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61