MAUDE MDR 9391606

MDR report key: 9391606
Report number: 3001845648-2019-00649
Event key: 0
Event type: 3
Date received: 2019-11-29
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: UNK AISLING HASSETT
Address: O HALLORAN ROAD NATIONAL TECHNOLOGY PARK LIMERICK
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	FGE CATHETER, BILIARY, DIAGNOSTIC	COOK IRELAND LTD	FGE		UNKNOWN	UNKNONW				R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0	1. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
15711055100400	M-Drain	Mermaid Medical A/S	FGE	2024-10-01
15711055110041	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055110409	M-Drain	Mermaid Medical A/S	FGE	2024-07-20
15711055120040	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055120453	M-Drain	Mermaid Medical A/S	FGE	2024-01-31
15711055000311	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000328	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000359	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000373	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000410	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000434	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000458	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000472	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000496	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000519	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000533	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000557	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000588	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000595	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000625	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000632	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000663	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000670	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000700	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000724	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000748	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000762	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000779	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000809	M-Drain	Mermaid Medical A/S	FGE	2016-09-24
15711055000816	M-Drain	Mermaid Medical A/S	FGE	2016-09-24

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K253832	FGE	Dilation Balloon Catheter	Mirco-Tech (Nanjing) Co., Ltd.	2026-04-24
510(k)	K251658	FGE	Endoflux™ Biliary & Pancreatic Stent Sets	Medi-Globe GmbH	2026-04-16
510(k)	K253987	FGE	BARE Wireguided Balloon Dilation Catheter (1235)	GIE Medical	2026-03-13
510(k)	K253132	FGE	Single use stone retrieval balloons	Zhejiang Chuangxiang Medical Technology Co., Ltd.	2026-03-06
510(k)	K251123	FGE	Niti-S Biliary Stent; Niti-S Biliary Slim M Stent	Taewoong Medical Co., Ltd.	2025-12-29

MAUDE MDR 9391606

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#