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	809	809
Material Separation	549	549
Adverse Event Without Identified Device or Use Problem	481	481
Material Integrity Problem	50	50
Component Misassembled	34	34
Material Frayed	28	28
Device Markings/Labelling Problem	20	20
Defective Component	17	17
Product Quality Problem	13	13
Tear, Rip or Hole in Device Packaging	13	13
Positioning Failure	12	12
Delivered as Unsterile Product	11	11
Appropriate Term/Code Not Available	11	11
Device Contaminated During Manufacture or Shipping	6	6
Component Missing	3	3
Dull, Blunt	3	3
Difficult to Open or Remove Packaging Material	2	2
Insufficient Information	2	2
Difficult to Remove	1	1
Degraded	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	1183	1183
Wound Dehiscence	209	209
No Consequences Or Impact To Patient	173	173
Unspecified Infection	158	158
Insufficient Information	96	96
Impaired Healing	66	66
Pain	59	59
Post Operative Wound Infection	54	54
Inflammation	51	51
Hematoma	45	45
Erythema	44	44
Seroma	44	44
Hemorrhage/Bleeding	38	38
Hernia	34	34
Necrosis	31	31
Not Applicable	26	26
Foreign Body In Patient	23	23
Scar Tissue	23	23
Abscess	23	23
Foreign Body Reaction	21	21
Itching Sensation	20	20
Fever	19	19
Fistula	18	18
Fluid Discharge	18	18
Purulent Discharge	18	18
Hypersensitivity/Allergic reaction	18	18
Swelling/ Edema	16	16
Cellulitis	16	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	15	15
Urinary Tract Infection	14	14
Unspecified Tissue Injury	13	13
Incontinence	13	13
Erosion	11	11
No Code Available	11	11
Local Reaction	11	11
Pocket Erosion	11	11
Skin Inflammation/ Irritation	9	9
Obstruction/Occlusion	9	9
Ulcer	8	8
Sepsis	8	8
Blood Loss	8	8
Failure to Anastomose	7	7
Rash	7	7
Granuloma	7	7
Swelling	6	6
Discomfort	5	5
Urinary Retention	5	5
Numbness	5	5
Abdominal Pain	4	4
Prolapse	3	3