UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-04 for UNK manufactured by Unk.

Event Text Entries

[19084834] Pt was horribly disfigured by a surgeon. Upon seeing the terrible results of his surgery, he promptly used a substance he called filler. The purpose of "filler" was to pad contour defects. Pt later learned that "filler" was liquid silicone. The liquid silicone was repeatedly injected into nose during many visits to his office over the span of 1 year. Since the time of the surgery and the injections of liquid silicone, pt's breathing has become increasingly poor and pt is subject to many nasal infections and sinus headaches. Pt has undergone many reconstructive operations using ear graft cartilage and some of the silicone was removed during these operations.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1023762
• MDR Report Key: 370569
• Date Received: 2002-01-04
• Date of Report: 2002-01-04
• Date of Event: 1987-11-06
• Date Added to Maude: 2002-01-11
• 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: 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: UNK
• Generic Name: SYRINGE
• Product Code: KGM
• Date Received: 2002-01-04
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 359691
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Required No Informationntervention	2002-01-04