* UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-01-15 for * UNK manufactured by Unk.

Event Text Entries

[221103] Pt had prostate surgery at hosp. Then pt had 28 radiation treatments. Ever since that time pt has been lightheaded (dizzy) with very tender feet and has to urinate 5 or 6 times a night.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1023846
• MDR Report Key: 372006
• Date Received: 2002-01-15
• Date of Report: 2002-01-09
• Date of Event: 1990-08-07
• Date Added to Maude: 2002-01-22
• 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: RADIATION
• Product Code: KPZ
• Date Received: 2002-01-15
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 361139
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly; 2. Deathisabilit	2002-01-15