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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-12-25 for * manufactured by *.

Event Text Entries

[15445786] Dr is illegally using silicone for lips and facial areas. Two months after injecting it in pt's lips, it lumped, pt's lips broke open, and half of one lip went numb. Pt went back to him for help and he said there was no way pt could prove he injected it, and refused to offer any type of help or advice. He said "don't bother to report me because no one would believe you". Pt wishes to remain annonymous and simply wants to stop him from mutilating anyone else without even taking responsibility.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1030597
• MDR Report Key: 504851
• Date Received: 2003-12-25
• Date of Report: 2003-12-25
• Date Added to Maude: 2004-01-08
• 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: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: SILICONE
• Product Code: KGM
• Date Received: 2003-12-25
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 493693
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-12-25