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	382	385
Material Separation	113	113
Adverse Event Without Identified Device or Use Problem	49	49
Detachment of Device or Device Component	46	46
Material Frayed	44	44
Appropriate Term/Code Not Available	29	29
Patient-Device Incompatibility	27	27
Defective Component	16	16
Device Markings/Labelling Problem	14	14
Material Integrity Problem	14	14
Component Misassembled	13	13
Material Twisted/Bent	12	12
Use of Device Problem	8	8
Material Split, Cut or Torn	6	6
Device Contaminated During Manufacture or Shipping	6	6
Migration	6	6
Difficult to Open or Close	6	6
Unraveled Material	5	5
Product Quality Problem	5	5
Device Slipped	4	4
Delivered as Unsterile Product	4	4
Component Missing	3	3
Packaging Problem	3	3
Activation, Positioning or Separation Problem	2	2
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Positioning Failure	2	2
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
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	525	528
No Consequences Or Impact To Patient	71	71
Insufficient Information	55	55
Wound Dehiscence	25	25
Hemorrhage/Bleeding	20	20
Unspecified Infection	17	17
Foreign Body In Patient	16	16
Pain	15	15
Swelling/ Edema	11	11
Not Applicable	8	8
No Code Available	8	8
Unspecified Tissue Injury	8	8
Post Operative Wound Infection	8	8
Hypersensitivity/Allergic reaction	7	7
Cyst(s)	6	6
Skin Irritation	5	5
Erosion	5	5
Inflammation	5	5
Skin Inflammation	5	5
Erythema	5	5
Unintended Radiation Exposure	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Granuloma	4	4
Blood Loss	4	4
Incontinence	4	4
Urinary Tract Infection	3	3
Abnormal Vaginal Discharge	3	3
Abscess	3	3
Prolapse	3	3
Fistula	2	2
Fluid Discharge	2	2
Scar Tissue	2	2
No Patient Involvement	2	2
Numbness	2	2
No Known Impact Or Consequence To Patient	2	2
Blister	2	2
Obstruction/Occlusion	2	2
Hematoma	2	2
Skin Inflammation/ Irritation	2	2
Sepsis	2	2
Impaired Healing	2	2
Paralysis	1	1
Seroma	1	1
Weakness	1	1
Fever	1	1
Swelling	1	1
Hernia	1	1
Foreign Body Reaction	1	1
Scarring	1	1
Laceration(s)	1	1

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