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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 2002-02-23 for * manufactured by *.

Event Text Entries

[272872] Went to see dermatologist. He injected silicone in reporter's nose and lip area. The nose is now bumpy and forming granuloma tissue on the surface. The injection on one surface of the nose was too superficial. The reporter was told by the doctor that silicone injections were very safe. He did not tell the reporter that this is not aproved by the fda. Reporter wish they could reverse this but it's too late now.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1024218
• MDR Report Key: 379360
• Date Received: 2002-02-23
• Date of Report: 2002-02-23
• Date of Event: 2002-01-04
• Date Added to Maude: 2002-03-06
• 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: 0
• 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: INJECTIBLE SILICONE
• Product Code: KGM
• Date Received: 2002-02-23
• 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: 368393
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-02-23