TPLC - Total Product Life Cycle

• Device: suture, absorbable, synthetic
• Product Code: GAN
• Regulation Number: 878.4830
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2018	400	400
2019	434	434
2020	278	278
2021	301	301
2022	328	328
2023	244	244

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	820	820
Material Separation	606	606
Adverse Event Without Identified Device or Use Problem	318	318
Detachment Of Device Component	68	68
Appropriate Term/Code Not Available	57	57
Tear, Rip or Hole in Device Packaging	42	42
Material Integrity Problem	41	41
Component Misassembled	23	23
Detachment of Device or Device Component	23	23
Material Frayed	20	20
Device Markings/Labelling Problem	18	18
Insufficient Information	11	11
Component Incompatible	10	10
Unsealed Device Packaging	7	7
Delivered as Unsterile Product	6	6
Degraded	6	6
Positioning Failure	6	6
Device Operates Differently Than Expected	4	4
Defective Component	4	4
Patient-Device Incompatibility	4	4
No Apparent Adverse Event	3	3
Dull, Blunt	3	3
Component Missing	2	2
Difficult to Open or Remove Packaging Material	2	2
Device Contaminated During Manufacture or Shipping	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Contamination /Decontamination Problem	1	1
Air Leak	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1
Device Fell	1	1
Extrusion	1	1
Failure to Form Staple	1	1
Material Erosion	1	1
Material Puncture/Hole	1	1
Difficult to Remove	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	852	852
No Clinical Signs, Symptoms or Conditions	660	660
Wound Dehiscence	127	127
Unspecified Infection	114	114
Not Applicable	86	86
Pain	60	60
Post Operative Wound Infection	54	54
Inflammation	46	46
Impaired Healing	45	45
Erythema	34	34
Hematoma	33	33
No Code Available	33	33
Hypersensitivity/Allergic reaction	32	32
Seroma	30	30
Foreign Body Reaction	24	24
Insufficient Information	23	23
Blood Loss	21	21
Necrosis	20	20
Hemorrhage/Bleeding	18	18
Itching Sensation	18	18
Hernia	17	17
Scar Tissue	16	16
Purulent Discharge	16	16
No Known Impact Or Consequence To Patient	16	16
Foreign Body In Patient	15	15
Abscess	15	15
Fistula	15	15
Rash	15	15
Skin Irritation	15	15
Fever	13	13
Erosion	12	12
Cellulitis	12	12
Swelling	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Fluid Discharge	11	11
Incontinence	10	10
Urinary Tract Infection	10	10
Local Reaction	9	9
Pocket Erosion	8	8
Unspecified Tissue Injury	8	8
Obstruction/Occlusion	7	7
Urinary Retention	7	7
Scarring	7	7
Failure to Anastomose	7	7
Granuloma	6	6
Sepsis	4	4
Ulcer	4	4
Skin Inflammation/ Irritation	4	4
Swelling/ Edema	3	3
Injury	3	3
Tissue Damage	3	3
Edema	3	3
Cerebrospinal Fluid Leakage	3	3
Adhesion(s)	3	3
Abdominal Pain	2	2
Bacterial Infection	2	2
Micturition Urgency	2	2
Fall	2	2
Burning Sensation	2	2
Abnormal Vaginal Discharge	2	2
Perforation of Vessels	2	2
Urinary Frequency	2	2
Urticaria	2	2
Discomfort	2	2
Nausea	2	2
Numbness	2	2
Blister	2	2
Drug Resistant Bacterial Infection	1	1
Hematuria	1	1
Chemical Exposure	1	1
Abdominal Distention	1	1
Pseudoaneurysm	1	1
Thromboembolism	1	1
Device Embedded In Tissue or Plaque	1	1
Fibrosis	1	1
Thrombosis/Thrombus	1	1
Renal Impairment	1	1
Paralysis	1	1
Perforation	1	1
Nerve Damage	1	1
Neurological Deficit/Dysfunction	1	1
Neuropathy	1	1
Tachycardia	1	1
Thrombosis	1	1
Peritonitis	1	1
Reaction	1	1
Vomiting	1	1
Uterine Perforation	1	1
Bone Fracture(s)	1	1
Muscular Rigidity	1	1
Myocardial Infarction	1	1
High Blood Pressure/ Hypertension	1	1
Exposure to Body Fluids	1	1
Bruise/Contusion	1	1
Capsular Contracture	1	1
Adult Respiratory Distress Syndrome	1	1
Cyst(s)	1	1
Diarrhea	1	1
Dysphagia/ Odynophagia	1	1
Ecchymosis	1	1