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

Model Number 5192501022

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 12/13/2021

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 prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, this device required replacement due to an infection.No other adverse patient effects were reported.

Manufacturer Narrative

D4 lot number: 7041173.B1 corrected from "adverse event and product problem" to "adverse event".

• 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: 13214968
• MDR Text Key: 283680782
• Report Number: 2125050-2022-00028
• Device Sequence Number: 1
• Product Code: FAE
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/24/2022

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 Model Number: 5192501022
• Device Catalogue Number: 519250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2022
• Initial Date FDA Received: 01/10/2022
• Supplement Dates Manufacturer Received: 03/24/2022
• Supplement Dates FDA Received: 03/24/2022
• 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: 70 YR
• Patient Sex: Male