MAUDE MDR 23919

MDR report key: 23919
Report number: 23919
Event key: 0
Event type: 3
Date of event: 1995-05-26
Date received: 1995-07-08
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 2
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Report source: U
Manufacturer link flag: N

Devices#

Seq, Brand, Generic table
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	PORT TITANIUM WITH GROSHONG	PORT A CATH	DAVOL, INC.	LJK						Y		Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	1995-07-08	0	1. O

Event Narratives#

D

Patient 1

THE PT WAS ADMITTED FOR OUTPATIENT SURGERY TO REMOVE THE PORT-A-CATH. THE CATHETER HAD FRAGMENTED AND WAS RETRIEVED IN APRIL BUT THE PT WAS NOT STABLE AT THE TIME FOR SURGERY.

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K974261	LJK	ACCURUN 135 TOXOPLASMA IGG POSITIVE CONTROL	Boston Biomedica, Inc.	1997-12-11
510(k)	K911771	LJK	ARD(TM) ANTIMICROBIAL REMOVAL DEVICE	Bd Becton Dickinson Vacutainer Systems Preanalytic	1991-07-01
510(k)	K861122	LJK	THE GOLDEN QUAD TEST (TOXO)	Microbiological Research Corp.	1987-02-02
510(k)	K861460	LJK	SOLID STATE CONTINUOUS FLOW CONTROL MODEL W/K101	Widran Urological Group, Ltd.	1986-05-02
510(k)	K832069	LJK	TOXO IPA KIT IAN INDIRECT FLUORESCENT	Bionetic Laboratory Products	1983-09-26