TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	356	359
Material Separation	110	110
Adverse Event Without Identified Device or Use Problem	54	54
Detachment of Device or Device Component	46	46
Material Frayed	39	39
Patient-Device Incompatibility	29	29
Device Markings/Labelling Problem	18	18
Appropriate Term/Code Not Available	17	17
Defective Component	16	16
Component Misassembled	13	13
Material Integrity Problem	11	11
Material Twisted/Bent	11	11
Migration	7	7
Difficult to Open or Close	7	7
Device Contaminated During Manufacture or Shipping	6	6
Use of Device Problem	6	6
Unraveled Material	5	5
Device Slipped	4	4
Material Split, Cut or Torn	3	3
Insufficient Information	3	3
Component Missing	3	3
Delivered as Unsterile Product	3	3
Packaging Problem	3	3
Product Quality Problem	3	3
Positioning Failure	2	2
Activation, Positioning or Separation Problem	1	1
Separation Problem	1	1
Wrong Label	1	1
Difficult to Remove	1	1
Material Deformation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	544	547
Insufficient Information	58	58
Wound Dehiscence	22	22
Hemorrhage/Bleeding	20	20
Unspecified Infection	19	19
Pain	14	14
Foreign Body In Patient	14	14
Swelling/ Edema	13	13
Unspecified Tissue Injury	13	13
Post Operative Wound Infection	9	9
Skin Inflammation/ Irritation	8	8
Hypersensitivity/Allergic reaction	7	7
Erosion	6	6
Inflammation	6	6
Skin Erosion	6	6
Incontinence	6	6
Scar Tissue	5	5
Erythema	4	4
Prolapse	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unintended Radiation Exposure	4	4
Cyst(s)	3	3
Urinary Tract Infection	3	3
Blister	2	2
Obstruction/Occlusion	2	2
Local Reaction	2	2
Numbness	2	2
Laceration(s)	2	2
Abnormal Vaginal Discharge	2	2
Abscess	2	2
Fluid Discharge	2	2
Granuloma	2	2
Tissue Breakdown	2	2
Autoimmune Disorder	1	1
Foreign Body Reaction	1	1
Fever	1	1
Paralysis	1	1
Seroma	1	1
Perforation	1	1
Hematoma	1	1
Hernia	1	1
Hematuria	1	1
Unspecified Kidney or Urinary Problem	1	1
Anaphylactic Shock	1	1
Calcium Deposits/Calcification	1	1
Chemosis	1	1
Tachycardia	1	1
Stenosis	1	1
Necrosis	1	1
Skin Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien, LP	II	Apr-12-2023