*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-29 for * manufactured by *.

Event Text Entries

[6541782] Wire placed during needle localization was in incorrect place. Wire was pulled but a small fragment broke off and remained in the patient's breast. Information was shared with the patient and included in the post procedure note.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4908432
• MDR Report Key: 4908432
• Date Received: 2015-05-29
• Date of Report: 2015-05-29
• Date of Event: 2015-01-30
• Report Date: 2015-05-29
• Date Reported to FDA: 2015-05-29
• Date Reported to Mfgr: 2015-07-13
• Date Added to Maude: 2015-07-13
• 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: *
• Generic Name: GUIDEWIRE
• Product Code: MIJ
• Date Received: 2015-05-29
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-05-29