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

Catalog Number	519260 / 91-9511SC / 519260
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 the available information, the implant was removed due to an unknown reason, and it is not known if the device was replaced.
Additional Manufacturer Narrative
Rod 1 and rod 2 were received for evaluation.Each of the rods were bent in four directions into approximately a 45-degree angle.Each time the rods were bent they maintained the flexed position.Each of the rods were bent in four directions into approximately a 45-degree angle.Each time the rods were bent they maintained the flexed position.The information received indicated that the implant was removed due to unknown cause, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.
Event or Problem Description
According to the available information, the implant was removed due to an unknown reason, and it is not known if the device was replaced.

• 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: 20976628
• Report Number: 2125050-2024-02128
• Device Sequence Number: 19864137
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 519260 / 91-9511SC / 519260
• Device Lot Number: 8608249_5192601400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• 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: 12/19/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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: 71 YR
• Patient Sex: Unknown