TPLC - Total Product Life Cycle

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Device	culture media, non-selective and non-differential
Product Code	JSG
Regulation Number	866.2300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings	257	257
Contamination	185	185
Contamination of Device Ingredient or Reagent	57	57
Device Markings/Labelling Problem	55	55
Microbial Contamination of Device	18	18
Device Contamination with Chemical or Other Material	11	11
Missing Information	6	6
False Negative Result	3	3
Contamination /Decontamination Problem	3	3
Fluid/Blood Leak	3	3
False Positive Result	2	2
Material Opacification	2	2
Output Problem	2	2
Adverse Event Without Identified Device or Use Problem	1	1
Particulates	1	1
Product Quality Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Component Missing	1	1
Separation Problem	1	1
Leak/Splash	1	1
Break	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Protective Measures Problem	1	1
Inaccurate Information	1	1
Connection Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	567	567
No Known Impact Or Consequence To Patient	21	21
No Consequences Or Impact To Patient	11	11
No Patient Involvement	7	7
Insufficient Information	4	4
Bacterial Infection	2	2
Unspecified Infection	1	1
Injury	1	1
Prolapse	1	1