TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	10	10
Device Contaminated During Manufacture or Shipping	8	8
Material Fragmentation	8	12
Device Contamination with Chemical or Other Material	8	8
Leak/Splash	7	7
Burst Container or Vessel	6	6
Inflation Problem	6	6
Material Deformation	6	6
Material Rupture	5	5
Contamination /Decontamination Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Fluid/Blood Leak	4	5
Packaging Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Disconnection	2	3
Material Split, Cut or Torn	2	2
Material Twisted/Bent	2	2
Corroded	2	3
Break	1	1
Output Problem	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Contamination	1	1
Moisture Damage	1	2
Difficult to Remove	1	1
Use of Device Problem	1	1
Component Missing	1	1
Decrease in Pressure	1	2
Material Separation	1	1
Component Misassembled	1	2
Gel Leak	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	89
Foreign Body In Patient	2	2
Pain	2	2
Perforation	1	1
Urinary Retention	1	1
Urinary Tract Infection	1	1
Chills	1	1
Discomfort	1	1
Fever	1	1
Hemorrhage/Bleeding	1	1
Incontinence	1	1
Unspecified Infection	1	1
Muscle Weakness	1	1
Nausea	1	1
Internal Organ Perforation	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Genital Bleeding	1	1
Drug Resistant Bacterial Infection	1	1