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

Catalog Number 91-9513SC / 519270

Device Problem Crack (1135)

Patient Problem Sensitivity of Teeth (2427)

Event Date 01/30/2023

Event Type  Injury  

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 to be associated.

Event Description

According to the available information the device was explanted and replaced due to not achieving sufficient erection.

Event Description

According to the available information the device was explanted and replaced due to not achieving sufficient erection.

Manufacturer Narrative

No functional abnormalities were noted with either rod 1 or rod 2.The information received indicated the device had a malfunction, but because no functional abnormalities were noted with the returned components, the complaint could not be confirmed as reported.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
• Type of Device: PENILE PROSTHESIS, ROD/CYLINDER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): MINNEAPOLIS; 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: 18151184
• MDR Text Key: 328307653
• Report Number: 2125050-2023-01417
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324809
• UDI-Public: 05708932324809
• 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: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 91-9513SC / 519270
• Device Lot Number: 8658506_5192702022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2022
• 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: 56 YR
• Patient Sex: Male