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	1028	1034
Adverse Event Without Identified Device or Use Problem	609	610
Fluid/Blood Leak	348	352
Device Appears to Trigger Rejection	135	135
Break	93	94
Off-Label Use	45	45
Patient-Device Incompatibility	42	50
Migration	41	41
No Apparent Adverse Event	40	40
Deflation Problem	38	38
Device Handling Problem	33	33
Use of Device Problem	26	26
Defective Device	25	25
Device Contaminated During Manufacture or Shipping	24	24
Appropriate Term/Code Not Available	22	22
Improper or Incorrect Procedure or Method	19	19
Infusion or Flow Problem	19	19
Connection Problem	18	18
Leak/Splash	17	17
Material Deformation	17	17
Patient Device Interaction Problem	15	15
Difficult to Open or Remove Packaging Material	14	14
Unintended Deflation	14	15
Product Quality Problem	14	14
Peeled/Delaminated	13	13
Device Contamination with Chemical or Other Material	10	10
Communication or Transmission Problem	8	8
Filling Problem	8	8
Insufficient Information	8	9
Detachment of Device or Device Component	8	8
Malposition of Device	7	7
Component Missing	6	6
Gel Leak	5	8
Nonstandard Device	4	10
Material Separation	4	4
Packaging Problem	4	4
Shipping Damage or Problem	4	4
Unsealed Device Packaging	4	4
Device Damaged Prior to Use	4	4
Material Discolored	3	3
Difficult to Remove	3	3
Material Integrity Problem	3	3
Expiration Date Error	3	3
Material Too Soft/Flexible	3	3
Inflation Problem	2	2
Labelling, Instructions for Use or Training Problem	2	2
Defective Component	2	2
Material Protrusion/Extrusion	2	2
Device Dislodged or Dislocated	2	2
Material Puncture/Hole	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Deformity/ Disfigurement	837	838
Failure of Implant	477	482
No Clinical Signs, Symptoms or Conditions	312	312
Unspecified Infection	260	261
Seroma	165	168
Capsular Contracture	162	165
Post Operative Wound Infection	137	137
Necrosis	93	96
Insufficient Information	77	77
Pain	41	53
Bacterial Infection	41	48
Wound Dehiscence	40	41
Breast Discomfort/Pain	39	43
Impaired Healing	39	42
Hematoma	38	38
Foreign Body Reaction	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	30	33
Rupture	27	28
Cellulitis	26	26
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