MAUDE Adverse Event Report: COLOPLAST A/S RESTORELLE L; RESTORELLE L RECT 24X8CM

Model Number	5014402400
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Erosion (1750); Pain (1994); Prolapse (2475); Hematuria (2558); Kidney Infection (4502); Dyspareunia (4505); Urinary Incontinence (4572); Fecal Urgency (4818)
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 device erosion, dyspareunia, chronic pelvic pain, and device explantation.
Event or Problem Description
Additional information received on 02/10/2023 indicates the following: beginning 1/1/2020 through 10/26/2021 the patient experienced urinary tract infections and recurrent rectocele.
Additional Manufacturer Narrative
Correction: medical device name, common device name, item number, catalogue number, udi number, medical device term, investigation conclusion term.The lot number was reviewed for complaint trend, nonconforming report and capa.¿ there was no complaint trend nor capas identified as associated with this lot.Devices met specification prior to release and no trends were noted.Trends were noted.
Event or Problem Description
Additional information received on 07/6/2023 indicates that on (b)(6) 2020 the patient experienced recurrent persistent fecal urgency/incontinence with hematuria.

• Brand Name: RESTORELLE L
• Common Device Name: RESTORELLE L RECT 24X8CM
• 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: 15926703
• Report Number: 2125050-2022-01359
• Device Sequence Number: 17740569
• Product Code: OTO
• UDI-Device Identifier: 05708932483964
• UDI-Public: 05708932483964
• Combination Product (Y/N): N
• PMA/510(K) Number: K132061
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 07/11/2023

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: 03/12/2021
• Device Model Number: 5014402400
• Device Catalogue Number: 501440
• Device Lot Number: 6102539
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/21/2022
• Supplement Date Received by Manufacturer: 02/10/2023; 07/06/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/16/2023; 07/11/2023
• Date Device Manufactured: 03/27/2018
• 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: Female