MAUDE MDR 8666427

MDR report key: 8666427
Report number: 3007420694-2019-00091
Event key: 0
Event type: 3
Date of event: 2019-05-02
Date received: 2019-06-04
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. KINGA STOLINSKA
Address: KS. WAWRZYNIAKA 2 KOMORNIKI, 62-05 PL
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	SYSTEM 2000	BATH, HYDRO-MASSAGE	ARJO HOSPITAL EQUIPMENT AB	ILJ	AR33312US0011						R	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-06-04	0	1. O

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00199874983844	Apollo Corp	APOLLO CORP.	ILJ	2025-11-17
05059441219576	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219583	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219590	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219606	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219613	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219620	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219637	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219644	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219651	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219668	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219675	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219682	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219699	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441219705	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441268277	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441268291	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441268307	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441306108	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441306115	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441306122	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310174	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310181	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310198	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310204	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310211	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310228	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310235	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310242	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25
05059441310259	Symbliss Bath	Arjohuntleigh AB	ILJ	2024-09-25

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K110994	ILJ	PARKER 500	Arjohuntleigh, Inc.	2011-07-06
510(k)	K082951	ILJ	IMMERSION HYDROBATH	Arjo Hospital Equipment AB	2009-04-08
510(k)	K052479	ILJ	MBATH 1000 (60)	Enneking Medical, Inc.	2006-01-26
510(k)	K040772	ILJ	PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM	Penner Manufacturing, Inc.	2004-04-05
510(k)	K012057	ILJ	CASCADE BATH, MODEL 6900	Penner Manufacturing, Inc.	2001-07-19

MAUDE MDR 8666427

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#