TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	12	12
Burst Container or Vessel	12	12
Material Puncture/Hole	12	12
Inflation Problem	9	9
Corroded	8	8
Device Contaminated During Manufacture or Shipping	7	7
Material Deformation	7	7
Device Contamination with Chemical or Other Material	6	6
Material Fragmentation	6	6
Fluid/Blood Leak	5	5
Break	5	5
Contamination /Decontamination Problem	5	5
Use of Device Problem	5	5
Pressure Problem	3	3
Tear, Rip or Hole in Device Packaging	3	3
Packaging Problem	3	3
Output Problem	2	2
Unsealed Device Packaging	2	2
Unable to Obtain Readings	2	2
Device Handling Problem	2	2
Material Twisted/Bent	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Noise, Audible	1	1
Melted	1	1
Gel Leak	1	1
Fracture	1	1
Component Misassembled	1	1
Material Separation	1	1
Material Rupture	1	1
Misassembled	1	1
Decrease in Pressure	1	1
Gas/Air Leak	1	1
Component Missing	1	1
Difficult to Remove	1	1
Moisture Damage	1	1
Contamination	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Integrity Problem	1	1
Crack	1	1
Physical Resistance/Sticking	1	1
Material Split, Cut or Torn	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	62	62
No Consequences Or Impact To Patient	26	26
No Known Impact Or Consequence To Patient	20	20
No Patient Involvement	11	11
Foreign Body In Patient	2	2
Unspecified Infection	1	1
Drug Resistant Bacterial Infection	1	1
Nausea	1	1
Genital Bleeding	1	1
Muscle Weakness	1	1
Perforation	1	1
Fever	1	1
Chills	1	1
Injury	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Pain	1	1
Urinary Tract Infection	1	1

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