TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	12	12
Inflation Problem	9	9
Leak/Splash	9	9
Burst Container or Vessel	9	9
Corroded	8	8
Material Fragmentation	8	8
Device Contaminated During Manufacture or Shipping	8	8
Device Contamination with Chemical or Other Material	6	6
Material Deformation	6	6
Contamination /Decontamination Problem	4	4
Fluid/Blood Leak	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Break	3	3
Packaging Problem	3	3
Unable to Obtain Readings	2	2
Disconnection	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Twisted/Bent	2	2
Output Problem	2	2
Device Handling Problem	2	2
Material Split, Cut or Torn	2	2
Melted	1	1
Moisture Damage	1	1
Unsealed Device Packaging	1	1
Decrease in Pressure	1	1
Difficult to Remove	1	1
Contamination	1	1
Fracture	1	1
Gel Leak	1	1
Material Separation	1	1
Use of Device Problem	1	1
Component Missing	1	1
Material Integrity Problem	1	1
Pressure Problem	1	1
Noise, Audible	1	1
Component Misassembled	1	1
Physical Resistance/Sticking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	75	75
No Consequences Or Impact To Patient	12	12
No Patient Involvement	9	9
No Known Impact Or Consequence To Patient	9	9
Foreign Body In Patient	2	2
Pain	2	2
Fever	1	1
Hemorrhage/Bleeding	1	1
Incontinence	1	1
Unspecified Infection	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Genital Bleeding	1	1
Discomfort	1	1
Muscle Weakness	1	1
Nausea	1	1
Internal Organ Perforation	1	1
Perforation	1	1
Urinary Retention	1	1
Urinary Tract Infection	1	1
Chills	1	1
Drug Resistant Bacterial Infection	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Inc.	II	Feb-04-2020