UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-06-30 for UNK manufactured by Unk.

Event Text Entries

[166326] Breast injected with silicone in 1990. Removed hardened silicone and replaced with implants.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 284330
• MDR Report Key: 284330
• Date Received: 2000-06-30
• Date of Report: 2000-06-26
• Date of Event: 2000-05-10
• Date Facility Aware: 2000-05-10
• Report Date: 2000-06-26
• Date Reported to FDA: 2000-06-26
• Date Added to Maude: 2000-07-06
• Event Key: 0
• Report Source Code: User Facility 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: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: UNK
• Generic Name: INJECTABLE SILICONE BREAST IMPLANT
• Product Code: KGM
• Date Received: 2000-06-30
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: UNKNOWN
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: U
• Device Sequence No: 1
• Device Event Key: 275152
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Device Sequence Number: 2

• Brand Name: *
• Date Received: 2000-06-30
• Implant Flag: N
• Device Sequence No: 2
• Device Event Key: 275154

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-06-30