TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
B. BRAUN MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
COLOPLAST
	SUBSTANTIALLY EQUIVALENT	4
CONVATEC LIMITED
	SUBSTANTIALLY EQUIVALENT	1
F&S MEDICAL SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
HAKKI MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU JIMUSHI MEDITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HOLLISTER INCORPORATED
	SUBSTANTIALLY EQUIVALENT	3
TELEFLEX MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT - KIT	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	142	142
Device Misassembled During Manufacturing /Shipping	84	84
Difficult to Open or Remove Packaging Material	65	65
Sharp Edges	58	58
Delivered as Unsterile Product	54	54
Difficult to Remove	51	51
Fluid/Blood Leak	35	35
Patient Device Interaction Problem	35	35
Biocompatibility	34	34
Break	34	34
Material Puncture/Hole	34	34
Deflation Problem	30	30
Contamination /Decontamination Problem	25	25
Product Quality Problem	25	25
Material Invagination	23	23
Packaging Problem	23	23
Unsealed Device Packaging	21	21
Material Deformation	20	20
Decrease in Pressure	19	19
Partial Blockage	18	18
Material Split, Cut or Torn	16	16
Difficult to Open or Close	16	16
Difficult to Insert	15	15
Device Handling Problem	13	13
Device Damaged Prior to Use	13	13
Burst Container or Vessel	13	13
Device Markings/Labelling Problem	12	12
Inaccurate Flow Rate	10	10
Material Too Rigid or Stiff	10	10
Insufficient Information	10	10
Material Rupture	9	9
Entrapment of Device	9	9
Dent in Material	8	8
Device Contamination with Chemical or Other Material	8	8
Leak/Splash	8	8
Detachment of Device or Device Component	7	7
Material Twisted/Bent	7	7
Appropriate Term/Code Not Available	6	6
Failure to Infuse	6	6
Fracture	6	6
Component Misassembled	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Defective Device	6	6
Material Fragmentation	5	5
Obstruction of Flow	3	3
Use of Device Problem	3	3
Inflation Problem	3	3
Inadequate Instructions for Healthcare Professional	3	3
Premature Separation	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	641	641
Urinary Tract Infection	158	158
No Consequences Or Impact To Patient	128	128
No Patient Involvement	94	94
No Known Impact Or Consequence To Patient	58	58
Pain	53	53
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	48
Unspecified Tissue Injury	43	43
Hemorrhage/Bleeding	40	40
Hematuria	29	29
Discomfort	27	27
Unspecified Infection	22	22
Sepsis	17	17
Tissue Breakdown	17	17
Blood Loss	10	10
Patient Problem/Medical Problem	7	7
Insufficient Information	7	7
Foreign Body In Patient	6	6
Bruise/Contusion	5	5
No Code Available	5	5
Genital Bleeding	5	5
Burning Sensation	5	5
Injury	5	5
Exsanguination	4	4
Irritation	4	4
Skin Inflammation/ Irritation	3	3
Perforation	3	3
Abrasion	3	3
Exposure to Body Fluids	3	3
Urinary Retention	3	3
Kidney Infection	2	2
Device Embedded In Tissue or Plaque	2	2
Distress	2	2
Cancer	2	2
Skin Tears	2	2
Swelling/ Edema	2	2
Laceration(s)	2	2
Fall	2	2
Rash	2	2
Local Reaction	2	2
No Information	2	2
Fungal Infection	2	2
Skin Irritation	2	2
Hypersensitivity/Allergic reaction	2	2
Abdominal Pain	2	2
Uremia	1	1
Fever	1	1
Localized Skin Lesion	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Urethral Stenosis/Stricture	1	1