LIPOSORBER LA-15 LDL 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 2001-01-29 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN UNK manufactured by Kaneka Corporation.

Event Text Entries

[234170] The patient felt discomfort on the eyes and fingertips after processing 240 ml of plasma. After that symptom, the pt experienced shock accompanied with vomit, convulsion, rigidity of upper part of the body and hypotension. The patient recovered in a few hrs after infusing saline, 10% nacl and hydrocortisone sodium succinate. The pt previously had received times 8, the ldl-apheresis treatment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2435151-2001-00001
• MDR Report Key: 314655
• Report Source: 01,05
• Date Received: 2001-01-29
• Date of Report: 2001-01-10
• Date of Event: 2000-11-30
• Date Mfgr Received: 2001-01-10
• Date Added to Maude: 2001-02-06
• 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
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LIPOSORBER LA-15 LDL ADSORPTION COLUMN
• Generic Name: LDL ADSORPTION SYSTEM
• Product Code: MMY
• Date Received: 2001-01-29
• 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: 304308
• Manufacturer: KANEKA CORPORATION
• Manufacturer Address: 3-2-4, NAKANOSHIMA KITA-KU OSAKA JA 530-8288

Patients

Patient Number	Treatment	Outcome	Date
1	150	1. Other	2001-01-29