TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
HUAIAN SEAMEN MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1278	1278
Adverse Event Without Identified Device or Use Problem	335	335
Material Separation	281	281
Detachment of Device or Device Component	121	121
Material Split, Cut or Torn	90	90
Delivered as Unsterile Product	41	41
Manufacturing, Packaging or Shipping Problem	33	33
Device Contaminated During Manufacture or Shipping	32	32
Component Misassembled	25	25
Packaging Problem	23	23
Material Frayed	21	21
Biocompatibility	17	17
Material Integrity Problem	16	16
Device Markings/Labelling Problem	14	14
Nonstandard Device	12	12
Inadequacy of Device Shape and/or Size	10	10
Defective Component	7	7
Product Quality Problem	6	6
Appropriate Term/Code Not Available	5	5
Patient-Device Incompatibility	5	5
Material Discolored	5	5
Component Missing	5	5
Material Twisted/Bent	4	4
Insufficient Information	4	4
Difficult to Remove	3	3
Device Contamination with Chemical or Other Material	3	3
Migration	3	3
Mechanical Problem	3	3
Dull, Blunt	3	3
Mechanics Altered	2	2
Unraveled Material	2	2
Contamination /Decontamination Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Component Incompatible	2	2
Use of Device Problem	1	1
Material Too Rigid or Stiff	1	1
Patient Device Interaction Problem	1	1
Unsealed Device Packaging	1	1
No Apparent Adverse Event	1	1
Difficult to Open or Remove Packaging Material	1	1
Illegible Information	1	1
Fracture	1	1
Entrapment of Device	1	1
Corroded	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1270	1270
No Consequences Or Impact To Patient	492	492
Inflammation	186	186
Erythema	140	140
Unspecified Infection	85	85
Swelling/ Edema	82	82
Pain	78	78
Insufficient Information	77	77
Fluid Discharge	76	76
Not Applicable	59	59
Hemorrhage/Bleeding	53	53
No Known Impact Or Consequence To Patient	45	45
Wound Dehiscence	42	42
Purulent Discharge	42	42
Skin Inflammation/ Irritation	32	32
Impaired Healing	29	29
Itching Sensation	29	29
Hypersensitivity/Allergic reaction	28	28
Post Operative Wound Infection	19	19
Pocket Erosion	15	15
No Code Available	15	15
Foreign Body Reaction	13	13
No Information	12	12
Fistula	11	11
Foreign Body In Patient	10	10
Granuloma	10	10
Unspecified Tissue Injury	9	9
Abscess	9	9
Blood Loss	8	8
Local Reaction	7	7
Necrosis	7	7
Discomfort	7	7
Fever	6	6
Failure to Anastomose	6	6
No Patient Involvement	6	6
Radiation Exposure, Unintended	5	5
Hernia	5	5
Unintended Radiation Exposure	5	5
Scar Tissue	5	5
Swelling	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bacterial Infection	3	3
Erosion	3	3
Hematoma	3	3
Obstruction/Occlusion	3	3
Cyst(s)	3	3
Sepsis	3	3
Burning Sensation	3	3
Eye Injury	3	3
Pneumothorax	3	3