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

Model Number	5014202400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Micturition Urgency (1871); Pain (1994); Scar Tissue (2060); Vesicovaginal Fistula (4512); Urinary Incontinence (4572)
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
As reported to coloplast, though not verified, legal representative stated the patient with this device experienced severe pelvic pain, urinary urgency problems, incontinence, scarring, recurrence, colovaginal fistula, and difficulty with daily activities.Patient had the device explanted.Patient then had another surgical intervention.
Additional Manufacturer Narrative
Additional information received on 03/21/2023 reported that the patient experienced e.Coli sepsis, erosion, bladder lesions and mass, bacterial vaginosis, fecal incontinence, stool in vagina, utis, vaginal calcified stone with yellow discharge, cystitis, dysuria, and fistulas.The patient underwent vaginal mesh excision, the revision/repair of the vaginal cuff under general anesthesia, cystoscopy and turbt, physical therapy, cystoscopy, vaginoscopy, robotic-assisted laparoscopic low anterior resection with colorectal anastomosis, resection of colovaginal fistula and flexible sigmoidoscopy.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
• 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: 16565659
• Report Number: 2125050-2023-00308
• Device Sequence Number: 17533011
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (Y/N): N
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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,Followup
• Report Date (Section B): 04/19/2023

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 Model Number: 5014202400
• Device Catalogue Number: 501420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 04/19/2023
• 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 Sex: Unknown