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	1113	1113
Adverse Event Without Identified Device or Use Problem	587	587
Fluid/Blood Leak	388	388
Device Appears to Trigger Rejection	116	116
Off-Label Use	74	74
Break	64	64
Patient-Device Incompatibility	48	48
Deflation Problem	40	40
Migration	34	34
Defective Device	34	34
Improper or Incorrect Procedure or Method	29	29
Device Handling Problem	27	27
Connection Problem	21	21
Use of Device Problem	21	21
Device Contaminated During Manufacture or Shipping	17	17
Device Contamination with Chemical or Other Material	17	17
Appropriate Term/Code Not Available	16	16
No Apparent Adverse Event	16	16
Infusion or Flow Problem	15	15
Difficult to Open or Remove Packaging Material	10	10
Leak/Splash	9	9
Peeled/Delaminated	9	9
Filling Problem	9	9
Unintended Deflation	9	9
Defective Component	9	9
Inflation Problem	8	8
Detachment of Device or Device Component	7	7
Material Deformation	6	6
Component Missing	6	6
Packaging Problem	5	5
Material Separation	5	5
Shipping Damage or Problem	4	4
Material Integrity Problem	4	4
Unsealed Device Packaging	4	4
Nonstandard Device	4	4
Patient Device Interaction Problem	3	3
Expiration Date Error	3	3
Insufficient Information	3	3
Device Damaged Prior to Use	3	3
Material Discolored	2	2
Material Puncture/Hole	2	2
Collapse	2	2
Device Dislodged or Dislocated	2	2
Gel Leak	2	2
Communication or Transmission Problem	2	2
Biofilm coating in Device	2	2
Device-Device Incompatibility	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Contamination /Decontamination Problem	1	1
Microbial Contamination of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Deformity/ Disfigurement	675	675
Failure of Implant	492	492
No Code Available	299	299
Unspecified Infection	282	282
No Clinical Signs, Symptoms or Conditions	220	220
Seroma	166	166
Capsular Contracture	147	147
Post Operative Wound Infection	105	105
Necrosis	80	80
Insufficient Information	65	65
No Consequences Or Impact To Patient	48	48
Wound Dehiscence	43	43
No Patient Involvement	40	40
Pain	36	36
Hematoma	34	35
Foreign Body Reaction	30	30
Breast Discomfort/Pain	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	28	28
Impaired Healing	26	26
Local Reaction	23	23
No Known Impact Or Consequence To Patient	21	21
Cellulitis	21	21
Bacterial Infection	19	19
Rupture	19	19
Lymphoma	17	17
Pocket Erosion	15	15
Swollen Lymph Nodes/Glands	15	15
Erythema	15	15
Cancer	13	13
Erosion	11	11
Hypersensitivity/Allergic reaction	10	10
Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL)	10	10
Inflammation	10	10
Swelling/ Edema	10	10
Fluid Discharge	9	9
Wrinkling	9	9
Fatigue	8	8
Unspecified Tissue Injury	8	8
Autoimmune Disorder	7	7
Fever	7	7
Breast Cancer	6	6
Myalgia	6	6
Scar Tissue	6	6
Depression	5	5
Abscess	5	5
Rash	5	5
Memory Loss/Impairment	5	5
Arthralgia	5	5
Anxiety	4	4
Itching Sensation	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	B. Braun Medical, Inc.	II	Nov-03-2023