TPLC - Total Product Life Cycle

• Device: suture, surgical, absorbable, polydioxanone
• Product Code: NEW
• Regulation Number: 878.4840
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DEMETECH CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
ETHICON, INC.
	SUBSTANTIALLY EQUIVALENT	3
FEELTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOOSIN MEDICAL SUPPLIES INC., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANS BIOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDITIME CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
OV WORLD CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
PDO MAX, INC.
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2018	898	898
2019	1122	1122
2020	1010	1010
2021	1464	1830
2022	1537	2757

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3447	4179
Material Separation	1074	1074
Adverse Event Without Identified Device or Use Problem	819	1063
Material Integrity Problem	146	146
Detachment of Device or Device Component	106	350
Detachment Of Device Component	92	92
Positioning Failure	73	73
Appropriate Term/Code Not Available	67	67
Positioning Problem	59	59
Material Frayed	54	54
Insufficient Information	36	36
Tear, Rip or Hole in Device Packaging	34	34
Device Markings/Labelling Problem	33	33
Device Operates Differently Than Expected	28	28
Component Misassembled	27	27
Material Split, Cut or Torn	20	20
Defective Component	20	20
Patient-Device Incompatibility	16	16
Failure To Adhere Or Bond	16	16
Material Twisted/Bent	14	136
Manufacturing, Packaging or Shipping Problem	12	12
Component Incompatible	12	12
Loss of or Failure to Bond	10	10
Material Protrusion/Extrusion	10	132
Delivered as Unsterile Product	9	9
Device Contaminated During Manufacture or Shipping	8	8
Device Fell	8	8
Migration	8	8
Inadequacy of Device Shape and/or Size	7	7
Component Missing	7	7
Migration or Expulsion of Device	6	6
Material Discolored	5	5
Failure to Form Staple	5	5
Patient Device Interaction Problem	5	127
Material Fragmentation	4	4
Entrapment of Device	4	4
Leak/Splash	4	4
Degraded	4	4
Loose or Intermittent Connection	3	3
Material Erosion	3	3
Fracture	3	125
Out-Of-Box Failure	3	3
Dull, Blunt	3	3
Difficult to Open or Remove Packaging Material	3	3
Device Dislodged or Dislocated	2	2
Incorrect Device Or Component Shipped	2	2
Material Deformation	2	2
Separation Failure	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Incomplete or Missing Packaging	2	2
Device Slipped	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Nonstandard Device	2	2
Unsealed Device Packaging	2	2
Product Quality Problem	2	2
Difficult to Remove	2	2
Air Leak	2	2
No Apparent Adverse Event	2	2
Noise, Audible	2	124
Separation Problem	1	1
Missing Information	1	1
Contamination	1	1
Crack	1	1
Material Disintegration	1	1
Mechanical Problem	1	1
Melted	1	1
Material Rupture	1	1
Device Appears to Trigger Rejection	1	1
Peeled/Delaminated	1	1
Device Issue	1	1
Difficult to Open or Close	1	1
Malposition of Device	1	1
Contamination of Device Ingredient or Reagent	1	1
Microbial Contamination of Device	1	1
Cut In Material	1	1
Dent in Material	1	1
Extrusion	1	1
Device Contamination with Chemical or Other Material	1	1
Mechanical Jam	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Packaging Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2494	2982
No Consequences Or Impact To Patient	2157	2157
Not Applicable	384	384
Wound Dehiscence	379	623
Unspecified Infection	248	370
No Code Available	138	138
Pain	130	130
Post Operative Wound Infection	104	226
Insufficient Information	85	207
Hemorrhage/Bleeding	82	83
Failure to Anastomose	82	82
Abscess	79	79
Hematoma	77	77
No Known Impact Or Consequence To Patient	75	75
Fistula	74	74
Hernia	72	72
Inflammation	69	69
Seroma	54	54
Foreign Body In Patient	52	296
Obstruction/Occlusion	49	49
Blood Loss	42	42
Unspecified Tissue Injury	42	42
Impaired Healing	38	160
Foreign Body Reaction	34	34
Fever	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	32	154
Necrosis	31	31
Hypersensitivity/Allergic reaction	30	30
Sepsis	30	31
Erythema	30	30
Pocket Erosion	29	29
Fluid Discharge	29	151
Swelling/ Edema	28	28
Purulent Discharge	25	25
Incontinence	23	23
Urinary Tract Infection	22	22
Discomfort	20	20
Swelling	19	19
Granuloma	19	19
Scar Tissue	18	18
Ulcer	15	15
Urinary Retention	13	13
Joint Dislocation	12	12
Adhesion(s)	11	11
Erosion	11	11
Local Reaction	10	10
Skin Inflammation/ Irritation	10	10
Thrombosis/Thrombus	9	9
No Patient Involvement	9	9
Paresis	9	9
Nausea	9	9
Cellulitis	9	9
Abdominal Pain	9	9
Pneumonia	8	8
Itching Sensation	8	8
Pleural Effusion	7	7
Loss of Range of Motion	7	7
Death	7	7
Device Embedded In Tissue or Plaque	7	7
Skin Irritation	7	7
Vomiting	5	5
Thrombosis	5	5
Peritonitis	5	5
Abdominal Distention	5	5
Muscle/Tendon Damage	5	5
Pneumothorax	5	5
Ischemia	5	5
Micturition Urgency	4	4
Perforation	4	4
Muscular Rigidity	4	4
Rash	4	4
Bacterial Infection	4	4
Blister	4	4
Respiratory Failure	4	4
Injury	4	4
Abnormal Vaginal Discharge	4	4
Tissue Damage	3	3
Deformity/ Disfigurement	3	3
Stenosis	3	3
Dizziness	3	3
No Information	3	3
Dysphagia/ Odynophagia	3	3
Edema	3	3
Anemia	3	3
Septic Shock	3	3
Myocardial Infarction	3	3
Nerve Damage	3	3
Damage to Ligament(s)	2	2
Scarring	2	2
Renal Failure	2	2
Arthritis	2	2
Bruise/Contusion	2	2
Calcium Deposits/Calcification	2	2
Bone Fracture(s)	2	2
Fatigue	2	2
Fibrosis	2	2
Restenosis	2	2
Reaction	2	2
Respiratory Tract Infection	2	2
Urinary Frequency	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Ethicon, Inc.	II	Dec-14-2022
2	Ethicon, Inc.	II	Sep-20-2022
3	Ethicon, Inc.	II	Feb-06-2020
4	Ethicon, Inc.	II	Oct-04-2019
5	Ethicon, Inc.	II	Apr-12-2019
6	Ethicon, Inc.	II	Jul-24-2018
7	Ethicon, Inc.	II	Apr-10-2018