TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	3
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
HAKKI MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Tear, Rip or Hole in Device Packaging	331	331
Adverse Event Without Identified Device or Use Problem	150	150
Device Misassembled During Manufacturing /Shipping	114	114
Sharp Edges	61	61
Difficult to Remove	48	48
Delivered as Unsterile Product	44	44
Patient Device Interaction Problem	37	37
Biocompatibility	34	34
Material Puncture/Hole	33	33
Fluid/Blood Leak	28	28
Contamination /Decontamination Problem	25	25
Material Invagination	23	23
Packaging Problem	21	21
Unsealed Device Packaging	21	21
Break	19	19
Decrease in Pressure	19	19
Partial Blockage	17	17
Deflation Problem	17	17
Difficult to Open or Remove Packaging Material	17	17
Difficult to Open or Close	16	16
Material Split, Cut or Torn	16	16
Difficult to Insert	15	15
Device Handling Problem	15	15
Material Deformation	14	14
Burst Container or Vessel	13	13
Insufficient Information	10	10
Device Markings/Labelling Problem	10	10
Device Damaged Prior to Use	10	10
Material Too Rigid or Stiff	10	10
Inaccurate Flow Rate	10	10
Material Rupture	10	10
Dent in Material	8	8
Entrapment of Device	8	8
Device Contamination with Chemical or Other Material	7	7
Appropriate Term/Code Not Available	6	6
Defective Device	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Fracture	6	6
Component Misassembled	6	6
Failure to Infuse	5	5
Material Fragmentation	5	5
Leak/Splash	4	4
Product Quality Problem	4	4
Material Twisted/Bent	4	4
Illegible Information	3	3
Detachment of Device or Device Component	3	3
Activation, Positioning or Separation Problem	3	3
Inflation Problem	3	3
Use of Device Problem	3	3
Improper Chemical Reaction	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	684	684
Urinary Tract Infection	170	170
No Consequences Or Impact To Patient	85	85
Pain	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	49	49
Unspecified Tissue Injury	43	43
Hemorrhage/Bleeding	40	40
Hematuria	32	32
No Known Impact Or Consequence To Patient	26	26
Unspecified Infection	24	24
Discomfort	21	21
No Patient Involvement	18	18
Sepsis	17	17
Tissue Breakdown	17	17
Insufficient Information	9	9
Blood Loss	8	8
Patient Problem/Medical Problem	7	7
Foreign Body In Patient	6	6
Burning Sensation	5	5
Injury	5	5
Genital Bleeding	5	5
Bruise/Contusion	5	5
Exsanguination	4	4
Irritation	3	3
Skin Inflammation/ Irritation	3	3
No Code Available	3	3
Exposure to Body Fluids	3	3
Distress	2	2
Local Reaction	2	2
Perforation	2	2
Kidney Infection	2	2
Rash	2	2
Fungal Infection	2	2
Cancer	2	2
Hypersensitivity/Allergic reaction	2	2
Laceration(s)	2	2
Fall	2	2
Skin Tears	2	2
Abdominal Pain	2	2
Swelling/ Edema	2	2
Fistula	1	1
Loss of consciousness	1	1
Pressure Sores	1	1
Bacterial Infection	1	1
Fainting	1	1
Device Embedded In Tissue or Plaque	1	1
Renal Failure	1	1
Fluid Discharge	1	1
Coma	1	1
Depression	1	1