TPLC - Total Product Life Cycle

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Device	suture, absorbable, synthetic
Regulation Description	Absorbable surgical gut suture.
Product Code	GAN
Regulation Number	878.4830
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	863	868
Material Separation	547	549
Adverse Event Without Identified Device or Use Problem	475	477
Material Integrity Problem	60	61
Material Frayed	36	36
Component Misassembled	36	36
Delivered as Unsterile Product	19	19
Device Markings/Labelling Problem	18	18
Defective Component	17	17
Positioning Failure	15	15
Product Quality Problem	13	13
Material Twisted/Bent	11	11
Tear, Rip or Hole in Device Packaging	7	7
Appropriate Term/Code Not Available	7	7
Device Contaminated During Manufacture or Shipping	6	6
Insufficient Information	4	4
Component Missing	4	4
Dull, Blunt	3	4
Difficult to Open or Remove Packaging Material	2	2
Degraded	1	1
Packaging Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1388	1394
Wound Dehiscence	213	215
Unspecified Infection	161	163
Insufficient Information	121	121
Impaired Healing	71	72
Seroma	50	50
Inflammation	49	49
Hematoma	49	49
Hemorrhage/Bleeding	48	48
Post Operative Wound Infection	47	47
Hernia	43	43
Pain	41	41
Necrosis	30	30
Erythema	27	27
Abscess	26	26
Foreign Body In Patient	25	26
Pocket Erosion	23	23
Hypersensitivity/Allergic reaction	21	21
Scar Tissue	21	21
Unspecified Tissue Injury	20	20
Fistula	19	19
Swelling/ Edema	18	18
Itching Sensation	18	18
Fluid Discharge	16	16
Purulent Discharge	16	16
Incontinence	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Urinary Tract Infection	14	14
Obstruction/Occlusion	12	12
Cellulitis	12	12
Fever	12	12
Skin Inflammation/ Irritation	10	10
Ulcer	10	10
Failure to Anastomose	9	9
Local Reaction	9	9
Rash	8	8
Sepsis	7	7
Erosion	7	7
Granuloma	7	7
Discomfort	7	7
Urinary Retention	7	7
Prolapse	6	6
Blister	6	6
Numbness	5	5
Muscular Rigidity	4	4
Abdominal Pain	4	4
Perforation of Vessels	3	3
Bacterial Infection	3	3
Fibrosis	3	3
Hypervolemia	3	3