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

Model Number 5192601400

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Skin Erosion (2075); Skin Inflammation/ Irritation (4545)

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the patient began to develop skin changes and almost impending erosion in the distal end of the penis along with skin excursions.The physician ended up having to move one cylinder at a time, and noted it almost seemed like an acute rejection of the device.The physician also noted it was not an infection as there was no purulent drainage and no other typical symptoms were noted.The device was not replaced.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROSTHESIS
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 12079908
• MDR Text Key: 258929058
• Report Number: 2125050-2021-00818
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/28/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Device Lot Number: 7915336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• 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: 48 YR