TPLC - Total Product Life Cycle

show TPLC since

Device	emergency response safety kit
Regulation Description	Surgical apparel.
Definition	This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OKI
Regulation Number	878.4040
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Application Program Problem: Dose Calculation Error	6	6
Device Markings/Labelling Problem	5	5
Patient-Device Incompatibility	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Application Program Problem: Medication Error	2	2
Device Displays Incorrect Message	2	2
Wrong Label	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Component Missing	1	1
Nonstandard Device	1	1
Inaccurate Information	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15	15
Insufficient Information	9	9