TPLC - Total Product Life Cycle

show TPLC since

Device	suture, absorbable, synthetic
Product Code	GAN
Regulation Number	878.4830
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	856	856
Material Separation	658	658
Adverse Event Without Identified Device or Use Problem	422	422
Material Integrity Problem	44	44
Tear, Rip or Hole in Device Packaging	36	36
Component Misassembled	31	31
Material Frayed	28	28
Device Markings/Labelling Problem	19	19
Defective Component	17	17
Appropriate Term/Code Not Available	16	16
Positioning Failure	12	12
Product Quality Problem	12	12
Delivered as Unsterile Product	9	9
Device Contaminated During Manufacture or Shipping	6	6
Degraded	6	6
Dull, Blunt	4	4
Insufficient Information	3	3
Component Missing	3	3
Detachment of Device or Device Component	3	3
Difficult to Open or Remove Packaging Material	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Component Incompatible	2	2
Material Puncture/Hole	1	1
Device Fell	1	1
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Packaging Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	961	961
No Consequences Or Impact To Patient	548	548
Wound Dehiscence	161	161
Unspecified Infection	131	131
Pain	61	61
Insufficient Information	60	60
Impaired Healing	55	55
Post Operative Wound Infection	52	52
Inflammation	49	49
Not Applicable	47	47
Hematoma	41	41
Erythema	38	38
Seroma	37	37
Hemorrhage/Bleeding	31	31
Hypersensitivity/Allergic reaction	28	28
Necrosis	27	27
Hernia	25	25
Foreign Body Reaction	23	23
Itching Sensation	22	22
Scar Tissue	22	22
Abscess	21	21
Fistula	18	18
Foreign Body In Patient	18	18
Purulent Discharge	17	17
No Code Available	15	15
Fever	15	15
Fluid Discharge	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Blood Loss	13	13
Cellulitis	13	13
Rash	13	13
Skin Irritation	12	12
Unspecified Tissue Injury	12	12
Incontinence	12	12
Urinary Tract Infection	12	12
Erosion	12	12
Swelling	11	11
Skin Inflammation/ Irritation	9	9
Swelling/ Edema	9	9
Local Reaction	9	9
Pocket Erosion	8	8
Obstruction/Occlusion	7	7
Granuloma	6	6
Failure to Anastomose	6	6
No Known Impact Or Consequence To Patient	6	6
Urinary Retention	6	6
Sepsis	5	5
Ulcer	5	5
Numbness	5	5
Discomfort	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Ethicon, Inc.	II	Jun-14-2024