TPLC - Total Product Life Cycle

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Device	non-surgical gown
Definition	A gown intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material
Product Code	OEA
Regulation Number	878.4040
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	3	3
Contamination /Decontamination Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Protective Measures Problem	2	2
Insufficient Information	2	2
Leak/Splash	2	2
Product Quality Problem	1	1
Unable to Obtain Readings	1	1
Improper or Incorrect Procedure or Method	1	1
Device Contamination with Body Fluid	1	1
Defective Device	1	1
Material Split, Cut or Torn	1	1
Packaging Problem	1	1
Device Contamination With Biological Material	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Operates Differently Than Expected	1	1
Compatibility Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	4	4
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	4	4
No Clinical Signs, Symptoms or Conditions	3	3
No Patient Involvement	2	2
Reaction	2	2
Skin Irritation	2	2
Discomfort	1	1
Exposure to Body Fluids	1	1
Burn(s)	1	1
Erythema	1	1
Unspecified Infection	1	1
Itching Sensation	1	1
Pain	1	1
Rash	1	1
Skin Inflammation	1	1
Nodule	1	1
Swelling/ Edema	1	1