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

Model Number	5015202400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Prolapse (2475)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to available information, the patient underwent a hysterectomy to treat uterovaginal prolapse.Subsequently, the prolapse recurred and the patient presented for revision surgery.At that time, it was discovered that the "y" arm of the device was broken in half between the "v" and the terminal end of the implant.A new device was used to repair the patient.Medwatch form mw5105163.
Additional Manufacturer Narrative
This report is in response to user facility medwatch form mw5105163.The lot # was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 13369329
• Report Number: 2125050-2022-00067
• Device Sequence Number: 19821702
• Product Code: OTO
• UDI-Device Identifier: 05708932528108
• UDI-Public: 05708932528108
• Combination Product (Y/N): N
• PMA/510(K) Number: K140116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2022

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: 09/22/2022
• Device Model Number: 5015202400
• Device Catalogue Number: 501520
• Device Lot Number: 6955695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 01/27/2022
• Date Device Manufactured: 09/23/2019
• 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