TPLC - Total Product Life Cycle

• Device: media, coupling, ultrasound
• Product Code: MUI
• Regulation Number: 892.1570
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ADVANCE MEDICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	1
HONY MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HR PHARMACEUTICALS, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANERKANG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PHARMACEUTICAL INNOVATIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
PHARMACEUTICAL INNOVATIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
QUOTIENT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
SAFERSONIC US, INC.
	SUBSTANTIALLY EQUIVALENT	1
ULTRAST, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	2	2
2019	2	2
2020	2	2
2021	13	13
2022	1	1
2023	2	2
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Nonstandard Device	5	5
Patient-Device Incompatibility	4	4
Device Markings/Labelling Problem	1	1
Insufficient Information	1	1
Excessive Heating	1	1
Overheating of Device	1	1
Microbial Contamination of Device	1	1
Burst Container or Vessel	1	1
Contamination	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Bacterial Infection	8	8
Itching Sensation	7	7
Erythema	5	5
Rash	5	5
Pain	3	3
Insufficient Information	2	2
Foreign Body Reaction	2	2
Hypersensitivity/Allergic reaction	1	1
Unspecified Infection	1	1
Skin Irritation	1	1
Burning Sensation	1	1
Burn, Thermal	1	1
Abdominal Distention	1	1
Tissue Breakdown	1	1
Skin Disorders	1	1
Pneumonia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Advance Medical Designs, Inc.	II	Sep-09-2023
2	Pharmaceutical Innovations, Inc.	II	Aug-20-2020
3	Turkuaz Saglik Hizmetleri Medikal Temizlik Kim. Ur. San. ve Tic. A.S.	II	Jan-20-2024