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

Model Number	5014202400
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Abnormal Vaginal Discharge (2123); Urinary Frequency / Polyuria (2275); Fungal Infection (2419); Dysuria (2684); Dyspareunia (4505)
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 pelvic pain, lower abdominal pain, dysuria, dyspareunia, vaginal discharge, candida vaginitis, urinary analysis with small leukocytes, cystoscopy, pelvic pain, hip pain, erosion of implanted vaginal device and other prosthetic materials.Patient had an emergency department visit for urinary frequency, vaginal discharge, and back pain.Patient had a vaginal exploration with device explantation for transvaginal device exposure under general anesthesia and estimated blood loss 25 ml.
Additional Manufacturer Narrative
Coloplast has not been provided any corroborating evidence to verify the information contained in this report.The lot number was reviewed for complaint trend, nonconforming report and capa.There were no nonconforming reports nor capas identified as associated with this lot number.There were several complaints against this lot; however, with various failure modes/harms.Therefore, this is not considered a trend.Devices met specification prior to release.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: 16183786
• Report Number: 2125050-2022-01495
• Device Sequence Number: 2633952
• Product Code: OTO
• UDI-Device Identifier: 05708932483834
• UDI-Public: 05708932483834
• Combination Product (Y/N): N
• PMA/510(K) Number: K112322
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• 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): 01/17/2023

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: 02/28/2017
• Device Model Number: 5014202400
• Device Catalogue Number: 501420
• Device Lot Number: 4010088
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 01/17/2023
• Date Device Manufactured: 03/13/2014
• 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: 47 YR
• Patient Sex: Unknown