MAUDE Adverse Event Report: SILICONE PENIS AUGMENTATION DEVICE; PROSTHESIS, PENIS, RIGID ROD

Device Problem Break (1069)

Patient Problems Pain (1994); Scarring (2061); Urinary Retention (2119); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/17/2020

Event Type  Injury  

Event Description

I had a permanent silicone penis augmentation device put in and it has broken into pieces doing exactly what was ordered by the surgeon/patent owner post surgery.It's causing pain, swelling, urinary restriction, scarring, and penis retraction.The surgeon/patent owner will only offer a consultation in (b)(6) 2020.He is indifferent to the damage and pain.The doctor is dr.(b)(6).I don't know his license no.Or the patent no.My name is (b)(6) phone number: (b)(6).I can provide pictures if it's important.Please contact me.My email address is valid but the below email request won't accept my email address as valid.The implant and the medications are available if i'm contacted.Fda safety report id # (b)(4).

• Brand Name: SILICONE PENIS AUGMENTATION DEVICE
• Type of Device: PROSTHESIS, PENIS, RIGID ROD
• MDR Report Key: 10726215
• MDR Text Key: 213053857
• Report Number: MW5097427
• Device Sequence Number: 1
• Product Code: FTQ
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 82