TPLC - Total Product Life Cycle

show TPLC since

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	1246	1251
Material Separation	850	852
Adverse Event Without Identified Device or Use Problem	567	569
Appropriate Term/Code Not Available	99	99
Detachment Of Device Component	73	73
Material Integrity Problem	55	56
Tear, Rip or Hole in Device Packaging	44	44
Material Frayed	40	40
Component Misassembled	38	38
Detachment of Device or Device Component	24	24
Device Markings/Labelling Problem	21	21
Defective Component	17	17
Product Quality Problem	14	14
Positioning Failure	12	12
Insufficient Information	11	11
Material Twisted/Bent	11	11
Delivered as Unsterile Product	11	11
Component Incompatible	10	10
Unsealed Device Packaging	7	7
Device Contaminated During Manufacture or Shipping	6	6
Degraded	6	6
Patient-Device Incompatibility	5	5
Component Missing	5	5
Incorrect Device Or Component Shipped	4	4
No Apparent Adverse Event	4	4
Device Operates Differently Than Expected	4	4
Dull, Blunt	4	5
Difficult to Open or Remove Packaging Material	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Extrusion	1	1
Material Erosion	1	1
Material Puncture/Hole	1	1
Device Fell	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Air Leak	1	1
Packaging Problem	1	1
Protective Measures Problem	1	1
Failure to Form Staple	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1280	1286
No Consequences Or Impact To Patient	889	889
Wound Dehiscence	275	277
Unspecified Infection	222	224
Insufficient Information	102	102
Not Applicable	88	88
Pain	81	81
Impaired Healing	76	77
Post Operative Wound Infection	70	70
Hematoma	67	67
Inflammation	63	63
Seroma	59	59
Erythema	51	51
No Code Available	48	48
Hemorrhage/Bleeding	44	44
Hernia	43	43
Hypersensitivity/Allergic reaction	38	38
Necrosis	37	37
Abscess	32	32
Foreign Body In Patient	27	28
Scar Tissue	26	26
Foreign Body Reaction	26	26
Itching Sensation	26	26
Fistula	24	24
Purulent Discharge	22	22
Blood Loss	22	22
Cellulitis	22	22
Pocket Erosion	21	21
Fever	20	20
Urinary Tract Infection	19	19
Fluid Discharge	19	19
No Known Impact Or Consequence To Patient	17	17
Rash	17	17
Swelling/ Edema	16	16
Unspecified Tissue Injury	16	16
Incontinence	16	16
Skin Irritation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Local Reaction	13	13
Erosion	12	12
Swelling	12	12
Failure to Anastomose	12	12
Obstruction/Occlusion	11	11
Granuloma	11	11
Skin Inflammation/ Irritation	10	10
Ulcer	10	10
Urinary Retention	9	9
Sepsis	9	9
Scarring	8	8
Discomfort	7	7