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 1998-12-16 for LIPOSORBER LA-15 LDL ADSORPTION COLUMN UNK manufactured by Kaneka Corp..

Event Text Entries

[116827] Pt's bloodflow was insufficient for treatment with ldl apheresis. After treatment of 2,100 ml of plasma using heparin as an anticoagulant, pt experienced hypotensive shock. Treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435151-1998-00008
MDR Report Key202451
Report Source01,05
Date Received1998-12-16
Date of Report1998-12-14
Date of Event1998-10-30
Date Mfgr Received1998-10-30
Device Manufacturer Date1997-11-01
Date Added to Maude1998-12-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIPOSORBER LA-15 LDL ADSORPTION COLUMN
Generic NameLDL ADSORPTION SYSTEM
Product CodeMMY
Date Received1998-12-16
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key196646
ManufacturerKANEKA CORP.
Manufacturer Address3-2-4 NAKANOSHIMA, KITA-KU OSAKA JA 530-8288


Patients

Patient NumberTreatmentOutcomeDate
131. Other 1998-12-16

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