MAUDE MDR 7926258

MDR report key: 7926258
Report number: MW5080273
Event key: 0
Event type: 3
Date received: 2018-10-01
Adverse event: 3
Product problem: 3
Patients in event: 0
Reporter occupation: 500
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Report source: P
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	OPEN-END FLEXI-TIP URETERAL CATHETER	CATHETER, URETERAL, GENERAL & PLASTIC SURGERY	COOK INCORPORATED	GBL							I	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2018-10-01	0	1. R

Event Narratives#

D

Patient 1

IT WAS REPORTED VIA OCCURRENCE REPORT THAT DURING PROCEDURE THERE WAS A DEVICE MALFUNCTION; THE LASER BRIDGE FOR THE RESECTOSCOPE SHEARED OFF A PIECE OF THE POLLACK CATHETER INSIDE OF THE PATIENT'S BLADDER. PATIENTS BLADDER WAS IRRIGATED AND FOREIGN BODY WAS NOT FOUND, SUSPECTED TO HAVE WASHED OUT.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00827002161542	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161559	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161566	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161573	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002161580	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002169807	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002170056	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147034	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147775	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002147782	Cook	COOK INCORPORATED	GBL	2016-11-04
00827002172371	Round Tip	COOK INCORPORATED	GBL	2016-10-06
00827002148703	Cook	COOK INCORPORATED	GBL	2016-09-30
00827002140271	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140325	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140332	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140400	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140417	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002140530	Round Tip	COOK INCORPORATED	GBL	2016-09-24
00827002148741	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002150362	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002158597	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002159402	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002167926	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002171602	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002172623	Whistle Tip	COOK INCORPORATED	GBL	2016-09-24
00827002178199	Cook	COOK INCORPORATED	GBL	2016-09-24
00827002179158	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002187900	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24
00827002188839	Cook	COOK INCORPORATED	GBL	2016-09-24
10827002140148	Flexi-Tip	COOK INCORPORATED	GBL	2016-09-24

MAUDE MDR 7926258

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

D

Related GUDID Devices By Product Code#