TPLC - Total Product Life Cycle

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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	59	59
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
Injury	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Genital Bleeding	1	1
Drug Resistant Bacterial Infection	1	1
Fever	1	1
Unspecified Infection	1	1
Muscle Weakness	1	1
Nausea	1	1
Pain	1	1
Perforation	1	1
Urinary Tract Infection	1	1
Chills	1	1

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