LIPOSORBER LA-15 ADSORPTION COLUMN UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2000-12-20 for LIPOSORBER LA-15 ADSORPTION COLUMN UNK manufactured by Kaneka Corporation.

Event Text Entries

[19493425] Ldl-apheresis was performed without any problems. This was the first treatment for the pt. About 5 hours after treatment; the pt had a hematochezia. The pt was recovered after transfusion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2435151-2000-00001
• MDR Report Key: 309455
• Report Source: 01,05
• Date Received: 2000-12-20
• Date of Report: 2000-12-11
• Date of Event: 2000-10-03
• Date Mfgr Received: 2000-12-11
• Date Added to Maude: 2000-12-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 0
• Manufacturer Street: 65 EAST 55TH ST., 12FL
• Manufacturer City: NEW YORK NY 10022
• Manufacturer Country: US
• Manufacturer Postal: 10022
• Manufacturer Phone: 2127054340
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIPOSORBER LA-15 ADSORPTION COLUMN
• Generic Name: LDL ADSORPTION SYSTEM
• Product Code: MMY
• Date Received: 2000-12-20
• Model Number: UNK
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 299403
• Manufacturer: KANEKA CORPORATION
• Manufacturer Address: 3-2-4 NAKANOSHIMA KITA-KU OSAKA JA 5308288

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2000-12-20