MAUDE MDR 9386342

MDR report key: 9386342
Report number: 1820334-2019-02983
Event key: 0
Event type: 3
Date received: 2019-11-27
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		PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA	COOK INC	PFJ							R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-27	0	1. D; 2. O

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00888937027860	DuoRipe	Coopersurgical, Inc.	PFJ	2025-12-01
00888937027877	DuoRipe	Coopersurgical, Inc.	PFJ	2025-12-01
20888937027864	DuoRipe	Coopersurgical, Inc.	PFJ	2025-12-01
20888937027871	DuoRipe	Coopersurgical, Inc.	PFJ	2025-12-01
H671CVX1000	CVX-RIPE	UTAH MEDICAL PRODUCTS, INC.	PFJ	2018-11-16
H671CVX1001	CVX-RIPE	UTAH MEDICAL PRODUCTS, INC.	PFJ	2018-11-16
00827002198913	Cook	COOK INCORPORATED	PFJ	2016-09-24
00827002481497	Cook	COOK INCORPORATED	PFJ	2016-09-24
10827002198910	Cook	COOK INCORPORATED	PFJ	2016-09-24
10827002481494	Cook	COOK INCORPORATED	PFJ	2016-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K143424	PFJ	UTAH CVX-RIPE	Utah Medical Products, Inc.	2015-08-28
510(k)	K131206	PFJ	COOK CERVICAL RIPENING BALLOON	Cook, Inc.	2013-09-27