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	814	819
Material Separation	512	514
Adverse Event Without Identified Device or Use Problem	433	435
Material Integrity Problem	56	57
Component Misassembled	36	36
Material Frayed	28	28
Defective Component	17	17
Device Markings/Labelling Problem	15	15
Positioning Failure	15	15
Product Quality Problem	13	13
Material Twisted/Bent	11	11
Delivered as Unsterile Product	11	11
Tear, Rip or Hole in Device Packaging	7	7
Device Contaminated During Manufacture or Shipping	6	6
Appropriate Term/Code Not Available	6	6
Insufficient Information	3	3
Component Missing	3	3
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	1296	1302
Wound Dehiscence	202	204
Unspecified Infection	139	141
Insufficient Information	104	104
Impaired Healing	69	70
Inflammation	49	49
Post Operative Wound Infection	47	47
Hemorrhage/Bleeding	44	44
Hematoma	44	44
Hernia	41	41
Seroma	41	41
Pain	39	39
Erythema	27	27
Necrosis	26	26
Abscess	26	26
Foreign Body In Patient	24	25
Pocket Erosion	21	21
Hypersensitivity/Allergic reaction	20	20
Itching Sensation	18	18
Fistula	17	17
Swelling/ Edema	17	17
Unspecified Tissue Injury	17	17
Scar Tissue	17	17
Fluid Discharge	16	16
Purulent Discharge	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Urinary Tract Infection	14	14
Incontinence	14	14
Fever	12	12
Cellulitis	12	12
Ulcer	10	10
Skin Inflammation/ Irritation	10	10
Failure to Anastomose	9	9
Local Reaction	9	9
Obstruction/Occlusion	9	9
Rash	8	8
Discomfort	7	7
Erosion	7	7
Sepsis	7	7
Granuloma	7	7
Blister	6	6
Numbness	5	5
Urinary Retention	5	5
Abdominal Pain	4	4
Prolapse	3	3
Foreign Body Reaction	3	3
Peritonitis	3	3
Perforation of Vessels	3	3
Adult Respiratory Distress Syndrome	3	3
Bacterial Infection	3	3