MAUDE Adverse Event Report: GENESIS MALLEABLE; PENILE PROTHESIS

Model Number 5192601400

Device Problems Material Erosion (1214); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Unspecified Infection (1930)

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.Once our evaluation is complete, a follow-up report will be submitted.Coloplast has not been provided any corroborating evidence to verify the information contained in this report.

Event Description

According to the available information, though not verified, revision case scheduled for (b)(6) 2021.The prosthesis appears eroded through the cc tips with impending erosion into urethra and through glans.

Manufacturer Narrative

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.The review of the device lot history record indicates this lot was processed through the validated sterilization cycle.Therefore, it was concluded the infection originated from source(s) other than the device.

Event Description

Additional information received further reported that an infection also occurred.The explant of the device was successful.Revision surgery has been scheduled for (b)(6) 2021 to re-insert a malleable prosthesis now that the patient has had time to recover from the infection.

• Brand Name: GENESIS MALLEABLE
• Type of Device: PENILE PROTHESIS
• MDR Report Key: 11121846
• MDR Text Key: 225247616
• Report Number: 2125050-2021-00017
• Device Sequence Number: 1
• Product Code: FAE
• UDI-Device Identifier: 05708932324748
• UDI-Public: 05708932324748
• Combination Product (y/n): N
• PMA/PMN Number: K040959
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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: Health Professional
• Device Model Number: 5192601400
• Device Catalogue Number: 519260
• Device Lot Number: 3079593
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 08/13/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR