BIOPOLYMERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for BIOPOLYMERS manufactured by Unk.

Event Text Entries

[123858063] Two women performed silicone butt injections back in (b)(6) 2013 illegally. Ever since i got those injections, i have experienced extreme chronic pain and often cannot move or perform any day to day functions. The silicone that was injected in my buttocks has migrated to my lower back and is causing excruciating pain and every day is getting worse. I went to my pcp a few months ago and told him what occurred and he ordered an mri of my glutes and lower back. He found the unknown substance and migration to my lower back and explained to me that stated i should seek a reconstructive surgeon that would perform this kind of surgery to get this removed since the pain is becoming unbearable. After doing lots of research, there are only two experienced doctors that have performed such surgical removal procedure but practice in other countries. So that means i would have to fly to get this removed, pay close to (b)(6) dollars for this procedure. While the pain this has cause often enables me to live a normal life, i wouldn? T want this woman causing any more damage to many more and would want to do all i can to stop them from causing more harm.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080509
• MDR Report Key: 7957602
• Date Received: 2018-10-10
• Date of Report: 2018-10-08
• Date of Event: 2013-09-18
• Date Added to Maude: 2018-10-11
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BIOPOLYMERS
• Generic Name: ELASTOMER, SILICONE BLOCK
• Product Code: MIB
• Date Received: 2018-10-10
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit	2018-10-10