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	1074	1074
Material Separation	779	779
Adverse Event Without Identified Device or Use Problem	546	546
Material Integrity Problem	54	54
Material Frayed	40	40
Tear, Rip or Hole in Device Packaging	37	37
Component Misassembled	37	37
Device Markings/Labelling Problem	21	21
Defective Component	17	17
Appropriate Term/Code Not Available	16	16
Product Quality Problem	13	13
Positioning Failure	12	12
Material Twisted/Bent	11	11
Delivered as Unsterile Product	11	11
Device Contaminated During Manufacture or Shipping	6	6
Degraded	6	6
Component Missing	4	4
Detachment of Device or Device Component	4	4
Dull, Blunt	4	4
Insufficient Information	3	3
Difficult to Open or Remove Packaging Material	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Component Incompatible	2	2
Material Puncture/Hole	1	1
Device Fell	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1271	1271
No Consequences Or Impact To Patient	548	548
Wound Dehiscence	233	233
Unspecified Infection	172	172
Insufficient Information	102	102
Impaired Healing	72	72
Pain	72	72
Inflammation	59	59
Post Operative Wound Infection	57	57
Hematoma	52	52
Seroma	49	49
Erythema	47	47
Not Applicable	47	47
Hemorrhage/Bleeding	44	44
Hernia	40	40
Necrosis	33	33
Hypersensitivity/Allergic reaction	31	31
Abscess	29	29
Foreign Body In Patient	27	27
Scar Tissue	25	25
Foreign Body Reaction	23	23
Itching Sensation	22	22
Pocket Erosion	21	21
Fistula	21	21
Purulent Discharge	20	20
Fever	19	19
Fluid Discharge	18	18
Cellulitis	17	17
Swelling/ Edema	16	16
Unspecified Tissue Injury	16	16
No Code Available	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Urinary Tract Infection	15	15
Rash	13	13
Incontinence	13	13
Blood Loss	13	13
Erosion	12	12
Skin Irritation	12	12
Local Reaction	11	11
Swelling	11	11
Obstruction/Occlusion	10	10
Failure to Anastomose	10	10
Skin Inflammation/ Irritation	9	9
Granuloma	9	9
Ulcer	8	8
Sepsis	8	8
Discomfort	7	7
No Known Impact Or Consequence To Patient	6	6
Urinary Retention	6	6
Numbness	5	5