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	360	363
Material Separation	109	109
Adverse Event Without Identified Device or Use Problem	57	57
Detachment of Device or Device Component	43	43
Material Frayed	38	38
Patient-Device Incompatibility	29	29
Device Markings/Labelling Problem	18	18
Appropriate Device Problem Term/Code Not Available	17	17
Defective Component	16	16
Component Misassembled	13	13
Material Integrity Problem	11	11
Material Twisted/Bent	10	10
Difficult to Open or Close	8	8
Migration	7	7
Device Contaminated During Manufacture or Shipping	6	6
Unraveled Material	5	5
Use of Device Problem	5	5
Device Slipped	4	4
Material Split, Cut or Torn	3	3
Delivered as Unsterile Product	3	3
Packaging Problem	2	2
Insufficient Device Problem Information	2	2
Positioning Failure	2	2
Human-Device Interface Problem	1	1
Material Deformation	1	1
Labelling, Instructions for Use or Training Problem	1	1
Separation Problem	1	1
Product Quality Problem	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	559	562
Insufficient Information	58	58
Wound Dehiscence	22	22
Hemorrhage/Blood Loss/Bleeding	21	21
Unspecified Infection	19	19
Swelling/ Edema	16	16
Foreign Body In Patient	14	14
Pain	14	14
Unspecified Tissue Injury	13	13
Post Operative Wound Infection	9	9
Skin Inflammation/ Irritation	8	8
Hypersensitivity/Allergic reaction	7	7
Inflammation	6	6
Erosion	6	6
Incontinence	6	6
Skin Erosion	6	6
Scar Tissue	5	5
Erythema	4	4
Unintended Radiation Exposure	4	4
Prolapse	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Cyst(s)	3	3
Abscess	3	3
Urinary Tract Infection	3	3
Tissue Breakdown	2	2
Granuloma	2	2
Abnormal Vaginal Discharge	2	2
Fluid Discharge	2	2
Laceration(s)	2	2
Numbness	2	2
Obstruction/Occlusion	2	2
Blister	2	2
Local Reaction	2	2
Foreign Body Reaction	1	1
Hematuria	1	1
Eye Pain	1	1
Chemosis	1	1
Autoimmune Disorder	1	1
Nodule	1	1
Salivary Hypersecretion	1	1
Seroma	1	1
Skin Infection	1	1
Calcium Deposits/Calcification	1	1
Unspecified Kidney or Urinary Problem	1	1
Hematoma	1	1
Tachycardia	1	1
Fistula	1	1
Stenosis	1	1
Necrosis	1	1
Urticaria	1	1

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