TPLC - Total Product Life Cycle

• Device: media, electroconductive
• Product Code: GYB
• Regulation Number: 882.1275
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
CAROL COLE COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ELECTRO-CAP INTL., INC.
	SUBSTANTIALLY EQUIVALENT	1
ENDYMED MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU XINBO ELECTRONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PREMIER NORTH AMERICA INC.
	SUBSTANTIALLY EQUIVALENT	1
SOMNOMEDICS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SPES MEDICA S.R.L
	SUBSTANTIALLY EQUIVALENT	1
SPES MEDICA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
TONE-A-MATIC INTERNATIONAL INC.
	SUBSTANTIALLY EQUIVALENT	1
TOP-RANK HEALTH CARE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
WUHAN GREENTEK PTY LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	3	3
2016	3	3
2017	4	4
2018	2	2
2019	3	3
2020	2	2
2021	4	4
2022	4	4
2023	6	6
2024	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10	10
Patient-Device Incompatibility	5	5
Use of Device Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Insufficient Information	4	4
Patient Device Interaction Problem	4	4
Appropriate Term/Code Not Available	2	2
Human-Device Interface Problem	2	2
Electrical /Electronic Property Problem	1	1
Failure to Conduct	1	1
Device Operates Differently Than Expected	1	1
Inadequate User Interface	1	1
Incomplete or Inadequate Connection	1	1
Output Problem	1	1
Split	1	1
Device Damaged by Another Device	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Irritation	10	10
Hypersensitivity/Allergic reaction	4	4
Eye Burn	3	3
Erythema	3	3
Discomfort	3	3
Hair Loss	3	3
Corneal Abrasion	2	2
Skin Inflammation/ Irritation	2	2
Abrasion	2	2
Edema	2	2
Itching Sensation	2	2
Local Reaction	2	2
Visual Disturbances	2	2
Rash	2	2
Burning Sensation	2	2
Insufficient Information	2	2
Pain	2	2
Partial thickness (Second Degree) Burn	2	2
Eye Pain	2	2
Full thickness (Third Degree) Burn	2	2
Superficial (First Degree) Burn	1	1
Death	1	1
Red Eye(s)	1	1
Nausea	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Malaise	1	1
Keratitis	1	1
Cardiac Arrest	1	1
Skin Erosion	1	1
Burn(s)	1	1
Skin Inflammation	1	1
Swelling	1	1
Reaction	1	1
Sudden Cardiac Death	1	1
Unspecified Tissue Injury	1	1
Contact Dermatitis	1	1
Blurred Vision	1	1
Convulsion/Seizure	1	1
Hemorrhage/Bleeding	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	National Distribution & Contracting Inc	I	Oct-13-2021
2	Natus Neurology Inc	II	Mar-19-2024
3	Parker Laboratories, Inc.	II	Apr-19-2024
4	Parker Laboratories, Inc.	II	Feb-29-2024
5	Pharmaceutical Innovations, Inc.	II	Jul-12-2019