MAUDE MDR 8053379

MDR report key: 8053379
Report number: 1219103-2018-00215
Event key: 0
Event type: 3
Date received: 2018-11-08
Adverse event: 0
Product problem: 3
Patients in event: 0
Reporter occupation: 0
Health professional: 3
Initial report to FDA: 3
Event location: 3

Manufacturer Contact#

Contact: EDWARD ALMEIDA
Address: 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
Phone: 508-508-5084
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
0	ELECTRODE ADULT 4.5X6.25 DEFIBRILATION	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)	COVIDIEN	MLN	22550A	22550A	819405X				N	Y
1	ELECTRODE ADULT 4.5X6.25 DEFIBRILATION	PACEMAKER, CARDIAC, EXTERNAL TRANSCUTANEOUS (NON-INVASIVE)	COVIDIEN	DRO	22550A	22550A	819405X				N	Y

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2018-11-08	0

Event Narratives#

N

Patient 1

THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

D

Patient 1

THE CUSTOMER STATES THE HYDROGEL REMAINS STUCK TO THE PLASTIC WHEN THE USER TRIES TO PEEL OFF THE ELECTRODE FOR USE.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10811331010302	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010319	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010326	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010333	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010340	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010357	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010364	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010371	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010388	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010395	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010401	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010418	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010425	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010432	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010449	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010456	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010463	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010647	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010654	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010661	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010678	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010685	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
10811331010692	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331010565	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331010596	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331010619	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331011098	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331011111	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331011135	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30
00811331011425	Defibrillation Electrodes	Tz Medical, Inc.	DRO	2020-12-30

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K012218	DRO	LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES	The Ludlow Company LP	2001-10-12
510(k)	K012404	DRO	K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85	Katecho, Inc.	2001-10-12
510(k)	K000660	DRO	ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413	Medical Data Electronics	2000-03-28
510(k)	K983196	DRO	PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)	Tz Medical, Inc.	1999-09-15
510(k)	K983232	DRO	PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT	Tz Medical, Inc.	1999-09-15

MAUDE MDR 8053379

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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