MAUDE MDR 9178405

MDR report key: 9178405
Report number: 9610824-2019-00056
Event key: 0
Event type: 3
Date of event: 2019-09-04
Date received: 2019-10-11
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MS MARTINA BENKERT
Address: INDUSTRIESTRASSE 1 DREIEICH, HESSEN 63303 GM
Report source: M
Manufacturer link flag: Y

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	REAGENT RED BLOOD CELLS BIOTESTCELL-I11	BIOTESTCELL-I11	BIO-RAD MEDICAL DIAGNOSTICS GMBH	KSZ		816021100	8929011-00				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-10-11	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05713494002829	ELDON SCHOOL KIT SKA 2511-30	Eldon Biologicals A/S	KSZ	2026-05-19
05713494002836	ELDON SCHOOL KIT SK 2511-30	Eldon Biologicals A/S	KSZ	2026-05-19
05713494002843	ELDON SCHOOL KIT SKA 2521-25	Eldon Biologicals A/S	KSZ	2026-05-19
05713494002683	ELDON MILITARY KIT MKA 2521-25	Eldon Biologicals A/S	KSZ	2024-07-05
05713494002690	ONE MAN KIT OKA 2511-1	Eldon Biologicals A/S	KSZ	2024-07-05
05713494002638	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2023-03-08
05713494002409	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2022-11-28
05713494002546	ELDON SCHOOL KIT SKA 2521-25	Eldon Biologicals A/S	KSZ	2022-10-04
10888234001553	Capture-R Select	IMMUCOR, INC.	KSZ	2022-09-03
03610522055685	IH-Card ABO Neutral	Bio-Rad Medical Diagnostics GmbH	KSZ	2022-03-09
05713494002287	ELDON SCHOOL KIT SKA 2511-30	Eldon Biologicals A/S	KSZ	2021-11-11
05713494002270	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2021-09-16
05713494002225	ELDON SCHOOL KIT SKA 2521-25	Eldon Biologicals A/S	KSZ	2021-05-31
05713494001990	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2021-04-27
10758750032846	ORTHO	ORTHO-CLINICAL DIAGNOSTICS, INC.	KSZ	2021-04-07
03610522123919	IH-Com V5.2	Bio-Rad Medical Diagnostics GmbH	KSZ	2021-02-18
05713494001976	ELDONBOX 2521-100 100 ELDONCARD 2521	Eldon Biologicals A/S	KSZ	2021-02-04
05713494000313	ELDONBOX 2521-100 100 ELDONCARD 2521	Eldon Biologicals A/S	KSZ	2021-02-04
05713494001808	ELDON SCHOOL KIT SK 2511-30	Eldon Biologicals A/S	KSZ	2020-12-12
05713494001952	ELDON HOME KIT HKA 2511-2	Eldon Biologicals A/S	KSZ	2020-12-12
05713494001969	ELDON HOME KIT HKA 2511-5	Eldon Biologicals A/S	KSZ	2020-12-12
05713494000306	ELDON HOME KIT HKA 2511-5	Eldon Biologicals A/S	KSZ	2020-12-12
05060496770066	Ortho Connect	BIOMEDICAL DATA SOLUTIONS LIMITED	KSZ	2020-11-18
08437014205008	DG Gel 8 Neutral	DIAGNOSTIC GRIFOLS SA	KSZ	2020-11-16
05713494001785	ELDONBOX 2511-100 100 ELDONCARD 2511	Eldon Biologicals A/S	KSZ	2020-11-04
05713494001792	ELDON SCHOOL KIT SKA 2511-30	Eldon Biologicals A/S	KSZ	2020-11-04
05713494001761	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2020-11-04
05713494001778	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2020-11-04
05713494001754	ELDON HOME KIT HKA 2511-1	Eldon Biologicals A/S	KSZ	2020-08-31
14987666543344	PK7400	Beckman Coulter, Inc.	KSZ	2020-07-06

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K810899	KSZ	TECHNICON AUTOGROUPER 16-C SYSTEM	Technicon Instruments Corp.	1981-05-05
510(k)	K790282	KSZ	ELDONCARD	Nordisk Infuser System	1979-05-04
510(k)	K771098	KSZ	BLOOD GROUPING SYS., BG-9	Technicon Instruments Corp.	1977-08-04
510(k)	K770185	KSZ	RH CONTROL DILUENT	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-03-14

MAUDE MDR 9178405

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#