MAUDE MDR 9391797

MDR report key: 9391797
Report number: 2183959-2019-67778
Event key: 0
Event type: 3
Date of event: 2019-11-08
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: ALYSON HARRIS
Address: 10700 BREN ROAD W MINNETONKA MN 55343 US
Phone: 408-408-4089
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	AMS INFLATABLE PENILE PROSTHESIS	DEVICE IMPOTENCE MECHANICAL/HYDRAULIC	BOSTON SCIENTIFIC CORPORATION	FHW	UNK-P-IPP	UNK-P-IPP					R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2019-11-29	0	1. H; 2. R

Event Narratives#

No narrative records found.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
05708932787109	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787116	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787123	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787130	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787147	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787888	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787925	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932787963	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932788007	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932788045	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932788083	Titan Prime	Coloplast A/S	FHW	2026-08-14
05708932778671	Titan	Coloplast A/S	FHW	2025-10-21
05708932778701	True-Lock	Coloplast A/S	FHW	2025-10-21
05701780278034	Titan	Coloplast A/S	FHW	2025-07-29
05708932768115	Titan Classic	Coloplast A/S	FHW	2024-10-29
05708932768139	Titan Classic	Coloplast A/S	FHW	2024-10-29
05708932768153	Titan Touch	Coloplast A/S	FHW	2024-10-29
05708932768177	Titan Touch	Coloplast A/S	FHW	2024-10-29
05701780276979	Titan	Coloplast A/S	FHW	2023-05-11
05701780277006	Titan	Coloplast A/S	FHW	2023-05-11
05708932072519	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072526	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072557	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072564	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072595	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072601	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072632	Titan®	Coloplast A/S	FHW	2017-10-16
05708932072649	Titan®	Coloplast A/S	FHW	2017-10-16
05708932661416	Titan	Coloplast A/S	FHW	2017-06-21
05708932539104	Titan	Coloplast A/S	FHW	2016-03-29

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
PMA	P000006S076	FHW	Titan Inflatable Penile Prosthesis	Coloplast Corp.	2026-08-13
PMA	P000006S074	FHW	Titan Inflatable Penile Prosthesis	Coloplast Corp.	2026-07-21
PMA	P000006S075	FHW	Titan Inflatable Penile Prosthesis	Coloplast Corp.	2026-07-20
PMA	P000006S072	FHW	Titan Inflatable Penile Prosthesis (IPP)	Coloplast Corp.	2026-06-02
PMA	P000006S071	FHW	Titan Inflatable Penile Prosthesis	Coloplast Corp.	2025-08-14

MAUDE MDR 9391797

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

Related GUDID Devices By Product Code#

Related PMN/PMA Records By Product Code#