SILICONE PENIS AUGMENTATION DEVICE
Received Oct 22, 2020 · Event occurred Aug 17, 2020
Report MW5097427 · MDR key 10726215
Device
Generic name
Prosthesis, Penis, Rigid Rod
Manufacturer
UnkProduct problems
- Break
Patient
42 YR
- Pain
- Scarring
- Urinary Retention
- Swelling/ Edema
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
- Pain
- Scarring
- Urinary Retention
- Swelling/ Edema
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
Narrative
Description of Event or Problem
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).