MAUDE Adverse Event Report: PENUMA PENUMA PENILE IMPLANT COSMETIC ENHANCEMENT; PROSTHESIS, PENILE

Device Problem Microbial Contamination of Device (2303)

Patient Problems Failure of Implant (1924); Post Operative Wound Infection (2446)

Event Date 02/17/2021

Event Type  Injury  

Event Description

Pt admitted for penile prosthesis wound infection and explant.Patient had the penuma device implanted in (b)(6), patient seen at (b)(6) with an infection related to the device.Department of urology requesting the product be submitted to the fda.I don't have any product details other than the name as this product is not used at (b)(6).Fda safety report id# (b)(4).

• Brand Name: PENUMA PENILE IMPLANT COSMETIC ENHANCEMENT
• Type of Device: PROSTHESIS, PENILE
• Manufacturer (Section D): PENUMA
• MDR Report Key: 11731562
• MDR Text Key: 247712862
• Report Number: MW5100993
• Device Sequence Number: 1
• Product Code: FAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR