TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
AHLSTROM NONWOVENS LLC
	SUBSTANTIALLY EQUIVALENT	2
ANDERSEN STERILIZERS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ANDERSEN STERILIZERS,INC.
	SUBSTANTIALLY EQUIVALENT	1
BH MEDICAL PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH 200 LLC
	SUBSTANTIALLY EQUIVALENT	1
CARDINAL HEALTH 200, LLC
	SUBSTANTIALLY EQUIVALENT	1
CARE ESSENTIALS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
CASE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU ZHANDE MEDICAL SUPPLIES CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MDK (SHANGHAI) MEDICAL PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	4
OWENS & MINOR (O&M) HALYARD, INC
	SUBSTANTIALLY EQUIVALENT	1
OWENS& MINOR HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
PLASMAPP CO,.LTD.
	SUBSTANTIALLY EQUIVALENT	1
PMS MEDIKAL AMBALAJ SANAYI VE TICARET LTD STI
	SUBSTANTIALLY EQUIVALENT	1
PMS TIBBI CIHAZLAR TEKNOLOJISI SAN VE TIC AS
	SUBSTANTIALLY EQUIVALENT	1
PMS TIP TEKNOLOJILERI SANAYI VE TICARET LIMITED STD
	SUBSTANTIALLY EQUIVALENT	1
SAFE SECURE PACKAGING CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SAFE SECURE PACKING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SIGMA MEDICAL SUPPLIES CORP.
	SUBSTANTIALLY EQUIVALENT	1
SIGMA MEDICAL SUPPLIES CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
STANDARD TEXTILE CO., INC.
	SUBSTANTIALLY EQUIVALENT	2
STERILERIGHT PACKAGING MFG., INC.
	SUBSTANTIALLY EQUIVALENT	1
STERIS CORPORATION
	SUBSTANTIALLY EQUIVALENT	4
TIANCHANG JIARUI PACKAGING MATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TURBETT SURGICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
TURBETT SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
WIPAK OY
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2016	20	20
2017	7	7
2018	22	22
2019	10	10
2020	21	21
2021	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Crack	15	15
Hole In Material	11	11
Device Disinfection Or Sterilization Issue	11	11
Problem with Sterilization	7	7
Material Discolored	5	5
Residue After Decontamination	5	5
Cut In Material	5	5
Material Puncture/Hole	4	4
Material Separation	3	3
Defective Component	3	3
Contamination	3	3
Device Contamination with Chemical or Other Material	3	3
Material Deformation	3	3
Material Integrity Problem	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Material Split, Cut or Torn	2	2
Tear, Rip or Hole in Device Packaging	2	2
Detachment of Device or Device Component	2	2
Material Fragmentation	2	2
Delivered as Unsterile Product	2	2
Failure To Adhere Or Bond	2	2
Break	2	2
Product Quality Problem	2	2
Shipping Damage or Problem	1	1
Component Missing	1	1
Out-Of-Box Failure	1	1
Metal Shedding Debris	1	1
Thermal Decomposition of Device	1	1
Fire	1	1
Device Emits Odor	1	1
Device Contaminated During Manufacture or Shipping	1	1
Connection Problem	1	1
Device Issue	1	1
Output Problem	1	1
Packaging Problem	1	1
Physical Property Issue	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	45	45
No Clinical Signs, Symptoms or Conditions	22	22
No Consequences Or Impact To Patient	11	11
No Patient Involvement	3	3
No Information	2	2
Insufficient Information	2	2
No Code Available	1	1
Missing Value Reason	1	1
Patient Problem/Medical Problem	1	1
Burn(s)	1	1
Failure of Implant	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Steris Corporation	II	Jan-21-2021
2	Steris Corporation	II	Feb-27-2018
3	TURBETT SURGICAL, LLC	II	May-18-2022