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

Catalog Number	519250 / 91-9509SC / 519250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information the patient complains of intermittent pain at the shaft of the penis, especially during intercourse.On physical examination - cylinders are well located.Swelling and fullness were noted at the distal shaft of the penis on the right side.Assessment ¿ recurrent infection of the penile prosthesis.Plan ¿ exploratory surgery, intraoperative assessment with removal of infected cylinders in case of infection.In case of adequate tissue and limited infection.Plan to perform a salvage procedure with intention to implant narrow cylinders.
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 capas that were confirmed to be associated.
Event or Problem Description
According to the available information the patient complains of intermittent pain at the shaft of the penis, especially during intercourse.On physical examination - cylinders are well located.Swelling and fullness were noted at the distal shaft of the penis on the right side.Assessment ¿ recurrent infection of the penile prosthesis.Plan ¿ exploratory surgery, intraoperative assessment with removal of infected cylinders in case of infection.In case of adequate tissue and limited infection.Plan to perform a salvage procedure with intention to implant narrow cylinders.
Additional Manufacturer Narrative
Two malleable rods were received for evaluation.Because examination of the returned components may not conclusively confirm or disprove the report of infection/pain, a microscopic examination was not performed.Based on the information provided quality accepts the physician¿s observations of such as the reason for surgical intervention.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, nonconformances and capas revealed no trends for this lot.

• 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: 18426611
• Report Number: 2125050-2024-00005
• Device Sequence Number: 12695422
• Product Code: FAE
• UDI-Device Identifier: 05708932324687
• UDI-Public: 05708932324687
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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 Expiration Date: 11/19/2025
• Device Catalogue Number: 519250 / 91-9509SC / 519250
• Device Lot Number: 7770240_5192502022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/02/2024
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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: 38 YR
• Patient Sex: Male