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	340	343
Material Separation	109	109
Adverse Event Without Identified Device or Use Problem	46	46
Detachment of Device or Device Component	42	42
Material Frayed	38	38
Patient-Device Incompatibility	23	23
Appropriate Term/Code Not Available	17	17
Defective Component	16	16
Device Markings/Labelling Problem	13	13
Component Misassembled	13	13
Material Integrity Problem	11	11
Material Twisted/Bent	11	11
Device Contaminated During Manufacture or Shipping	6	6
Use of Device Problem	6	6
Difficult to Open or Close	6	6
Unraveled Material	5	5
Migration	5	5
Device Slipped	4	4
Material Split, Cut or Torn	3	3
Component Missing	3	3
Delivered as Unsterile Product	3	3
Packaging Problem	3	3
Product Quality Problem	3	3
Insufficient Information	2	2
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	522	525
Insufficient Information	54	54
Hemorrhage/Bleeding	20	20
Wound Dehiscence	19	19
Unspecified Infection	15	15
Pain	14	14
Swelling/ Edema	13	13
Foreign Body In Patient	13	13
Unspecified Tissue Injury	8	8
Hypersensitivity/Allergic reaction	7	7
Post Operative Wound Infection	6	6
Unintended Radiation Exposure	4	4
Erosion	4	4
Erythema	4	4
Incontinence	4	4
Inflammation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cyst(s)	3	3
Prolapse	3	3
Urinary Tract Infection	3	3
Blister	2	2
Skin Inflammation/ Irritation	2	2
Numbness	2	2
Scar Tissue	2	2
Fluid Discharge	2	2
Abscess	2	2
Abnormal Vaginal Discharge	2	2
Granuloma	2	2
Local Reaction	1	1
Obstruction/Occlusion	1	1
Foreign Body Reaction	1	1
Perforation	1	1
Hematoma	1	1
Paralysis	1	1
Seroma	1	1
Fever	1	1
Hernia	1	1
Necrosis	1	1
Laceration(s)	1	1
Unspecified Kidney or Urinary Problem	1	1
Hematuria	1	1
Calcium Deposits/Calcification	1	1
Stenosis	1	1
Anaphylactic Shock	1	1
Tachycardia	1	1
Chemosis	1	1
Skin Infection	1	1
Urticaria	1	1
Eye Pain	1	1
Low Blood Pressure/ Hypotension	1	1

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