TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	68	68
Break	33	33
Material Separation	15	15
Material Integrity Problem	7	7
Improper Chemical Reaction	3	3
Material Split, Cut or Torn	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	35	35
Unspecified Infection	28	28
Insufficient Information	21	21
Wound Dehiscence	19	19
Pain	13	13
Pocket Erosion	9	9
Hemorrhage/Bleeding	9	9
Foreign Body In Patient	8	8
Impaired Healing	7	7
Swelling/ Edema	7	7
Erythema	7	7
Post Operative Wound Infection	6	6
Hypersensitivity/Allergic reaction	5	5
Abscess	4	4
Inflammation	4	4
Urinary Retention	4	4
Skin Inflammation/ Irritation	3	3
Purulent Discharge	3	3
Urinary Tract Infection	2	2
Fluid Discharge	2	2
Nerve Damage	2	2
Seroma	2	2
Fever	2	2
Incontinence	2	2
Itching Sensation	2	2
Perforation	2	2
Hematoma	2	2
Cyst(s)	2	2
Skin Discoloration	1	1
Foreign Body Reaction	1	1
Cellulitis	1	1
Obstruction/Occlusion	1	1
Hernia	1	1
Abrasion	1	1
Prolapse	1	1
Failure to Anastomose	1	1
Eye Injury	1	1
Pneumonia	1	1
Muscle/Tendon Damage	1	1
Anaphylactic Shock	1	1
Unspecified Tissue Injury	1	1
Necrosis	1	1
Bacterial Infection	1	1
Sepsis	1	1
Deformity/ Disfigurement	1	1
Drug Resistant Bacterial Infection	1	1
Fistula	1	1
Neuropathy	1	1
Ambulation Difficulties	1	1