MAUDE Adverse Event Report: PROEXTENDER; PENILE PROSTHESIS

Device Problem Insufficient Information (3190)

Patient Problems Nerve Damage (1979); Neurological Deficit/Dysfunction (1982); Occlusion (1984); Tissue Damage (2104); Complaint, Ill-Defined (2331); Numbness (2415)

Event Date 06/14/2013

Event Type  Injury  

Event Description

I wore a penis extender/traction device that caused me a cavernosa nerve injury.Although, i am healthy with no underlying health problems, i now have ed, penile numbness, penile tissue loss, veno-occlusive dysfunction and multiple other symptoms.I am being treated at (b)(6) as someone who has undergone a radical prostatectomy.

• Brand Name: PROEXTENDER
• Type of Device: PENILE PROSTHESIS
• MDR Report Key: 4006057
• MDR Text Key: 4707184
• Report Number: MW5037704
• 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: Patient
• Type of Report: Initial
• Report Date: 08/06/2014

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 109