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

Catalog Number 91-9509SC / 519250

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

According to the available information the device was explanted and replaced due to unknown reasons.

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.

• Brand Name: GENESIS MALLEABLE PENILE PROSTHESIS
• Type of Device: 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: 19099646
• MDR Text Key: 340054637
• Report Number: 2125050-2024-00581
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 91-9509SC / 519250
• Device Lot Number: 8458926_5192501400
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 03/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male