TPLC - Total Product Life Cycle

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Device	cleaner, ultrasonic, medical instrument
Product Code	FLG
Regulation Number	880.6150
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Improper Chemical Reaction	4	4
Use of Device Problem	3	3
Problem with Removal of Enzymatic Cleaner	2	2
Fire	2	2
Leak/Splash	2	2
Product Quality Problem	2	2
Contamination /Decontamination Problem	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Unintended Electrical Shock	2	2
Lack of Effect	1	1
Device Reprocessing Problem	1	1
Patient Device Interaction Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Failure of Device to Self-Test	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Output below Specifications	1	1
Device Difficult to Maintain	1	1
No Apparent Adverse Event	1	1
Misassembled	1	1
False Positive Result	1	1
Improper or Incorrect Procedure or Method	1	1
Obstruction of Flow	1	1
Patient-Device Incompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Corneal Edema	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Insufficient Information	4	4
No Consequences Or Impact To Patient	4	4
Electric Shock	3	3
Headache	2	2
No Information	2	2
Cough	1	1
Eye Pain	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
Irritation	1	1
Rash	1	1
No Known Impact Or Consequence To Patient	1	1
Needle Stick/Puncture	1	1