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

Catalog Number	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	11/20/2024
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 capas that were confirmed in veeva to be associated.
Event or Problem Description
According to the available information, implant was removed for an unspecified procedure / reason and replaced at a later date.The details surrounding the explant were not provided.

• 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: 20878908
• Report Number: 2125050-2024-02040
• Device Sequence Number: 18096284
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040959
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/09/2024

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: 05/17/2020
• Device Catalogue Number: 91-9511SC / 519260
• Device Lot Number: 4639789_5192601400
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2015
• 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: 73 YR
• Patient Sex: Male