MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE Y CONTOUR; SURGICAL MESH

Model Number	5014202400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Prolapse (2475); Abdominal Cramps (2543); Dysuria (2684); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced lower pelvic cramping, pain that runs from lower back to vaginal area, incomplete bladder emptying, post void incontinence, lateral cystocele, rectocele, vaginal vault prolapse, dysuria, standing to fully empty bladder, lateral cystocele, rectocele, vaginal vault prolapse, pelvic pain with sharp pains throughout left groin and recurrent anterior prolapse with incomplete bladder emptying that causes recurrent urinary tract infections.Patient had a cystoscopy that noted erythema consistent with incomplete bladder emptying and no signs of erosion, kinking or other abnormalities.Patient had a robotic assisted sacrocolpopexy, paravaginal repair, revision of the unknown pelvic device, release of a prior pubo-urethral device from another manufacturer and was discharged with a catheter.
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts 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.

• Brand Name: RESTORELLE Y CONTOUR
• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16189111
• Report Number: 2125050-2023-00030
• Device Sequence Number: 5794894
• Product Code: OTN
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/23/2018
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 4620067
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2022
• Supplement Date Received by Manufacturer: 03/08/2023; 03/28/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 03/10/2023; 04/14/2023
• Date Device Manufactured: 06/24/2015
• 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: 72 YR
• Patient Sex: Unknown