TPLC - Total Product Life Cycle

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Device	immunohistochemistry reagents and kits
Definition	according to the regs..."..used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin.
Product Code	NJT
Regulation Number	864.1860
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Improper or Incorrect Procedure or Method	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Incorrect Or Inadequate Test Results	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Patient-Device Incompatibility	1	1
Device Markings/Labelling Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Information	1	1
False Negative Result	1	1
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Headache	7	7
Pain	6	6
Rash	6	6
Reaction	5	5
Insufficient Information	4	4
Cancer	3	3
Hypersensitivity/Allergic reaction	2	2
Reaction, Injection Site	1	1
No Patient Involvement	1	1
Therapeutic Effects, Unexpected	1	1
Arthralgia	1	1
Death	1	1
No Clinical Signs, Symptoms or Conditions	1	1