IH-LISS RACK 813510100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-04 for IH-LISS RACK 813510100 manufactured by Bio-rad Medical Diagnostics Gmbh.

MAUDE Entry Details

Report Number9610824-2019-00049
MDR Report Key8959355
Date Received2019-09-04
Date of Report2019-09-04
Date of Event2019-08-07
Date Mfgr Received2019-08-07
Date Added to Maude2019-09-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS MARTINA BENKERT
Manufacturer StreetINDUSTRIESTRASSE 1
Manufacturer CityDREIEICH, HESSEN 63303
Manufacturer CountryGM
Manufacturer Postal63303
Manufacturer G1BIO-RAD MEDICAL DIAGNOSTICS GMBH
Manufacturer StreetINDUSTRIESTRASSE 1
Manufacturer CityDREIEICH, 63303
Manufacturer CountryGM
Manufacturer Postal Code63303
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameIH-LISS RACK
Generic NameIH-LISS RACK; 10 RACKS
Product CodeKSF
Date Received2019-09-04
Catalog Number813510100
Lot Number760000006
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIO-RAD MEDICAL DIAGNOSTICS GMBH
Manufacturer AddressINDUSTRIESTRASSE 1 DREIEICH, 63303 GM 63303


Patients

Patient NumberTreatmentOutcomeDate
10 2019-09-04

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