TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	35	35
Device Handling Problem	23	23
Difficult to Open or Remove Packaging Material	16	16
Break	13	13
Device Appears to Trigger Rejection	7	7
Adverse Event Without Identified Device or Use Problem	5	5
Defective Device	4	4
Device Contamination with Chemical or Other Material	4	4
Patient-Device Incompatibility	3	3
Inaccurate Information	3	3
Improper or Incorrect Procedure or Method	3	3
Device Contaminated During Manufacture or Shipping	2	2
Off-Label Use	2	2
Device Markings/Labelling Problem	2	2
Material Disintegration	2	2
Material Puncture/Hole	2	2
Deflation Problem	2	2
Packaging Problem	2	2
Device Reprocessing Problem	2	2
Gel Leak	2	2
Burst Container or Vessel	1	1
Output Problem	1	1
Device Damaged Prior to Use	1	1
Unsealed Device Packaging	1	1
Defective Component	1	1
Contamination	1	1
Microbial Contamination of Device	1	1
Patient Device Interaction Problem	1	1
Material Discolored	1	1
Use of Device Problem	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	53	53
No Clinical Signs, Symptoms or Conditions	41	41
Insufficient Information	13	13
Capsular Contracture	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Unspecified Infection	3	3
Pain	3	3
No Consequences Or Impact To Patient	3	3
Nausea	2	2
Post Operative Wound Infection	2	2
Seroma	2	2
Headache	2	2
Wound Dehiscence	1	1
Fatigue	1	1
Necrosis	1	1
Purulent Discharge	1	1
Gastritis	1	1
Foreign Body Reaction	1	1
Rash	1	1
Ptosis	1	1
No Patient Involvement	1	1
Dyspnea	1	1
Deformity/ Disfigurement	1	1
Granuloma	1	1