UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-02-23 for UNK * manufactured by Na.

Event Text Entries

[196875] Pt's dialysis shunt clotted off on event date. Pt was transferred to hospital where a thrombectomy was performed three days later. Pts returned to reporting hospital to continue rehabilitation two days later.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 322923
• MDR Report Key: 322923
• Date Received: 2001-02-23
• Date of Report: 2001-02-16
• Date of Event: 1999-01-30
• Date Added to Maude: 2001-03-30
• 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: DIALYSIS SHUNT
• Product Code: FIQ
• Date Received: 2001-02-23
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 312382
• Manufacturer: NA
• Manufacturer Address: NA NA *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2001-02-23