TPLC - Total Product Life Cycle

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Device	tissue expander and accessories
Product Code	LCJ
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	1014	1020
Adverse Event Without Identified Device or Use Problem	597	598
Fluid/Blood Leak	346	350
Device Appears to Trigger Rejection	131	131
Break	91	92
Off-Label Use	45	45
Patient-Device Incompatibility	40	48
Migration	40	40
No Apparent Adverse Event	39	39
Deflation Problem	37	37
Device Handling Problem	33	33
Use of Device Problem	25	25
Defective Device	25	25
Device Contaminated During Manufacture or Shipping	23	23
Appropriate Term/Code Not Available	22	22
Infusion or Flow Problem	19	19
Improper or Incorrect Procedure or Method	19	19
Connection Problem	18	18
Material Deformation	17	17
Leak/Splash	17	17
Patient Device Interaction Problem	15	15
Unintended Deflation	14	15
Product Quality Problem	14	14
Peeled/Delaminated	13	13
Difficult to Open or Remove Packaging Material	13	13
Device Contamination with Chemical or Other Material	10	10
Insufficient Information	8	9
Communication or Transmission Problem	8	8
Detachment of Device or Device Component	8	8
Filling Problem	7	7
Malposition of Device	7	7
Component Missing	6	6
Gel Leak	5	8
Nonstandard Device	4	10
Unsealed Device Packaging	4	4
Device Damaged Prior to Use	4	4
Shipping Damage or Problem	4	4
Packaging Problem	4	4
Material Integrity Problem	3	3
Material Too Soft/Flexible	3	3
Difficult to Remove	3	3
Material Separation	3	3
Expiration Date Error	3	3
Material Discolored	3	3
Collapse	2	2
Inflation Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Material Puncture/Hole	2	2
Dull, Blunt	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Deformity/ Disfigurement	825	826
Failure of Implant	475	480
No Clinical Signs, Symptoms or Conditions	307	307
Unspecified Infection	257	258
Seroma	164	167
Capsular Contracture	157	160
Post Operative Wound Infection	137	137
Necrosis	91	94
Insufficient Information	74	74
Pain	41	53
Breast Discomfort/Pain	39	43
Wound Dehiscence	39	40
Impaired Healing	38	41
Bacterial Infection	38	45
Hematoma	38	38
Foreign Body Reaction	31	31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	33
Rupture	27	28
Cellulitis	25	25
Local Reaction	22	22
Erythema	18	24
Swollen Lymph Nodes/Glands	15	15
Lymphoma	14	14
Pocket Erosion	14	14
Swelling/ Edema	14	26
Hypersensitivity/Allergic reaction	13	13
Erosion	12	12
Fluid Discharge	11	14
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)	10	10
Cancer	9	12
Wrinkling	9	9
Inflammation	9	16
Autoimmune Disorder	8	8
Scar Tissue	8	12
Fatigue	8	18
Rash	7	15
Burning Sensation	6	15
Unspecified Tissue Injury	6	6
Breast Cancer	6	6
Weight Changes	5	12
Arthralgia	5	10
Skin Inflammation/ Irritation	5	5
Myalgia	5	12
Emotional Changes	5	5
Abscess	5	5
Chest Pain	4	12
Discomfort	4	4
Depression	4	5
Numbness	4	10
Fever	4	9