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

Catalog Number 91-9513SC / 519270

Device Problem Material Too Soft/Flexible (4007)

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

Event Date 07/14/2022

Event Type  Injury  

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 Description

According to the available information provided by our distributor partner endoctor, a 57-year-old patient, who had his prosthesis implanted on (b)(6) 2014, sought the doctor on (b)(6) 2022 reporting that his prosthesis does not maintain its axial rigidity.The patient underwent an ultrasound to verify the presence of the prosthesis, and the decision was made to replace the prosthesis.Replacement surgery was performed on (b)(6) 2022 during which reconstruction of the corpora cavernosa was performed followed by implant of a new prosthesis.

• 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: 18357641
• MDR Text Key: 330898099
• Report Number: 2125050-2023-01614
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932957090
• UDI-Public: 5708932957090
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 12/19/2023

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 91-9513SC / 519270
• Device Lot Number: 3375321N_5192701022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2023
• Date Device Manufactured: 10/30/2012
• 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: 57 YR
• Patient Sex: Male