MAUDE Adverse Event Report: COLOPLAST A/S GENESIS MALLEABLE PENILE PROSTHESIS; PENILE PROSTHESIS, ROD/CYLINDER

Catalog Number	91-9511SC / 519260
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was reviewed for complaint trend, non-conforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no non-conforming reports or capa's that were confirmed in veeva to be associated.
Event or Problem Description
According to the available information the device was explanted due to an infection.
Additional Manufacturer Narrative
Correction h6 impact code f1903 removed and replaced with f1905.The device was not returned for evaluation.However, because examination of the returned components may not conclusively confirm or disprove the report of infection, quality accepts the physician¿s observations of such as the reason for surgical intervention.The review of the device lot history record indicates this lot was processed through the validated sterilization cycle.Therefore, it was concluded the infection originated from source(s) other than the device.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed in veeva to be associated.
Event or Problem Description
According to additional information received, a new device [replacement] was implanted in (b)(6) 2024.

• Brand Name: GENESIS MALLEABLE PENILE PROSTHESIS
• Common Device Name: PENILE PROSTHESIS, ROD/CYLINDER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19034441
• Report Number: 2125050-2024-00529
• Device Sequence Number: 20593520
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 91-9511SC / 519260
• Device Lot Number: 8652367_5192602022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/21/2022
• 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: 80 YR
• Patient Sex: Male