UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-21 for UNK * manufactured by Unk.

Event Text Entries

[74541] Exchange of rt breast implant.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 127911
• MDR Report Key: 127911
• Date Received: 1997-10-21
• Date of Report: 1997-10-20
• Date of Event: 1997-10-17
• Date Facility Aware: 1997-10-17
• Report Date: 1997-10-20
• Date Added to Maude: 1997-10-27
• 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
• 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 Details

• Brand Name: UNK
• Generic Name: BREAST IMPLANT
• Product Code: FWN
• Date Received: 1997-10-21
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 125151
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-10-21