TPLC - Total Product Life Cycle

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Device	source, brachytherapy, radionuclide
Regulation Description	Radionuclide brachytherapy source.
Product Code	KXK
Regulation Number	892.5730
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	58	58
Inaccurate Information	22	22
Unclear Information	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Device Contamination with Chemical or Other Material	4	4
Positioning Failure	3	3
Insufficient Device Problem Information	3	3
Material Twisted/Bent	3	3
Labelling, Instructions for Use or Training Problem	3	3
Fitting Problem	3	3
Lack of Maintenance Documentation or Guidelines	3	3
Material Integrity Problem	2	2
Mechanical Jam	2	2
Device Markings/Labelling Problem	2	2
Material Fragmentation	2	2
Break	2	2
Inadequate Instructions for Healthcare Professional	2	2
Packaging Problem	2	2
Wrong Label	2	2
Missing Information	2	2
Unintended Ejection	2	2
Device Damaged Prior to Receipt by User	1	1
Unsealed Device Packaging	1	1
Component Misassembled	1	1
Material Deformation	1	1
Component Missing	1	1
Detachment of Device or Device Component	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	113	114
Post Operative Wound Infection	4	4
Necrosis	3	3
Unintended Radiation Exposure	3	3
Needle Stick/Puncture	2	2
Cerebral Edema	2	2
Insufficient Information	2	2
Confusion/ Disorientation	1	1
Unspecified Infection	1	1
Fatigue	1	1
Malaise	1	1
No Consequences Or Impact To Patient	1	1