MAUDE MDR 8960330

MDR report key: 8960330
Report number: 1820334-2019-02216
Event key: 0
Event type: 3
Date received: 2019-09-04
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 1
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: MR. LARRY POOL
Address: 750 DANIELS WAY BLOOMINGTON IN 47404 US
Phone: 812-812-8123
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	UNKNOWN	UNKNOWN	COOK INC	BWC	N/A	UNKNOWN	UNKNOWN				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-09-04	0

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
04250105630770	ScalpelCric	VBM Medizintechnik GmbH	BWC	2026-05-08
04250105629736	ScalpelCric	VBM Medizintechnik GmbH	BWC	2022-12-21
04250105628111	n.a.	VBM Medizintechnik GmbH	BWC	2020-11-09
14250105628118	n.a.	VBM Medizintechnik GmbH	BWC	2020-11-09
15019315110528	Portex	ICU MEDICAL, INC.	BWC	2017-05-29
35019315110522	Portex	ICU MEDICAL, INC.	BWC	2017-05-29
00827002077966	Patil	COOK INCORPORATED	BWC	2015-10-24
00827002082519	Arndt	COOK INCORPORATED	BWC	2015-10-24
00827002089501	Patil	COOK INCORPORATED	BWC	2015-10-24
00827002094130	Cook	COOK INCORPORATED	BWC	2015-10-24
00827002103382	Cook	COOK INCORPORATED	BWC	2015-10-24
04026704111671	RUSCH	TELEFLEX INCORPORATED	BWC	2015-10-16
15019315010989	Portex	ICU MEDICAL, INC.	BWC	2015-09-01

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K200190	BWC	ScalpelCric	VBM Medizintechnik GmbH	2020-10-30
510(k)	K160200	BWC	Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set	Cook Incorporated	2017-02-17
510(k)	K153761	BWC	Emergency Transtracheal Airway Catheter	Cook Incorporated	2016-09-22
510(k)	K130405	BWC	RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET	Teleflex Medical	2013-11-06
510(k)	K050166	BWC	PORTEX EMERGENCY CRICOTHYROIDOTOMY KIT	Smiths Medical	2005-05-26