TPLC - Total Product Life Cycle

• Device: wrap, sterilization
• Product Code: FRG
• Regulation Number: 880.6850
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AHLSTROM-MUNKSJO NONWOVENS LLC
	SUBSTANTIALLY EQUIVALENT	1
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CARE ESSENTIALS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
COMERCIALIZADORA BREVER
	SUBSTANTIALLY EQUIVALENT	1
DUKAL LLC
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU ZHANDE MEDICAL SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
KENPAX INTERNATIONAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
KM CORP.
	SUBSTANTIALLY EQUIVALENT	1
MDK (SHANGHAI) MEDICAL PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDICOM GROUP, INC
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
O&M HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
OWENS & MINOR (O&M) HALYARD, INC
	SUBSTANTIALLY EQUIVALENT	1
OWENS & MINOR (O&M) HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
OWENS& MINOR HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRIMED MEDICAL PRODUCTS INC.
	SUBSTANTIALLY EQUIVALENT	2
QIANJIANG KINGPHAR MEDICAL PACKAGING & PRINTING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SAFE SECURE PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SAFESECURE MEDICAL INFECTION CONTROL TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGMA MEDICAL SUPPLIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SOLIDENCE SURGICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STERILERIGHT PACKAGING MFG., INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TURBETT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
WIPAK OY
	SUBSTANTIALLY EQUIVALENT	7
WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	10	10
2020	21	21
2021	9	9
2022	4	4
2023	13	13
2024	20	20

Device Problems	MDRs with this Device Problem	Events in those MDRs
Crack	15	15
Material Discolored	12	12
Material Puncture/Hole	9	9
Material Split, Cut or Torn	7	7
Residue After Decontamination	5	5
Difficult to Open or Remove Packaging Material	3	3
Material Integrity Problem	3	3
Product Quality Problem	3	3
Break	2	2
Defective Component	2	2
Material Deformation	2	2
Material Separation	2	2
Device Contamination with Chemical or Other Material	2	2
Appropriate Term/Code Not Available	2	2
Fire	1	1
Output Problem	1	1
Insufficient Information	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Contamination	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Shipping Damage or Problem	1	1
Delivered as Unsterile Product	1	1
Packaging Problem	1	1
Unexpected Color	1	1
Device Emits Odor	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	53	53
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	7	7
Insufficient Information	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Patient Problem/Medical Problem	1	1
Failure of Implant	1	1
No Code Available	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Jan-21-2021
2	TURBETT SURGICAL, LLC	II	May-18-2022
3	Turbett Surgical, Inc.	II	Jan-30-2023
4	Turbett Surgical, Inc.	II	Aug-04-2022