TPLC - Total Product Life Cycle

show TPLC since

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