TPLC - Total Product Life Cycle

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Device	drape, surgical
Regulation Description	Surgical drape and drape accessories.
Product Code	KKX
Regulation Number	878.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Puncture/Hole	27	27
Adverse Event Without Identified Device or Use Problem	27	27
Material Split, Cut or Torn	13	13
Hole In Material	13	13
Contamination /Decontamination Problem	10	10
Device Contamination with Chemical or Other Material	8	8
Break	7	7
Contamination	4	4
Detachment of Device or Device Component	4	4
Appropriate Term/Code Not Available	4	4
Torn Material	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Operates Differently Than Expected	3	3
Device Contamination with Body Fluid	3	3
Delivered as Unsterile Product	3	3
Product Quality Problem	2	2
Material Rupture	2	2
Fluid Leak	2	2
Tear, Rip or Hole in Device Packaging	2	2
Material Perforation	2	2
Leak/Splash	2	2
Peeled/Delaminated	2	2
Improper or Incorrect Procedure or Method	2	2
Connection Problem	2	2
Defective Device	2	2
Material Integrity Problem	2	2
Packaging Problem	2	2
Insufficient Information	2	2
No Apparent Adverse Event	1	1
Material Protrusion/Extrusion	1	1
No Flow	1	1
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1
Device Displays Incorrect Message	1	1
Patient-Device Incompatibility	1	1
Device Packaging Compromised	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Markings/Labelling Problem	1	1
Fitting Problem	1	1
Device Damaged Prior to Use	1	1
Split	1	1
Material Fragmentation	1	1
Failure To Adhere Or Bond	1	1
Loss of or Failure to Bond	1	1
Material Discolored	1	1
Material Disintegration	1	1
Flaked	1	1
Material Separation	1	1
Unsealed Device Packaging	1	1
Difficult to Insert	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	76	76
No Clinical Signs, Symptoms or Conditions	24	24
Skin Tears	12	12
Blister	11	11
Pain	11	11
Erythema	9	9
Skin Inflammation/ Irritation	9	9
Skin Burning Sensation	8	8
No Information	7	7
No Consequences Or Impact To Patient	6	6
Insufficient Information	6	6
Injury	4	4
Rash	4	4
Burn(s)	4	4
Ulceration	4	4
Skin Irritation	3	3
Foreign Body In Patient	3	3
No Patient Involvement	2	2
Reaction	2	2
Discomfort	2	2
Local Reaction	2	2
Hemorrhage/Bleeding	2	2
Irritation	2	2
Itching Sensation	1	1
Vessel Or Plaque, Device Embedded In	1	1
Bacterial Infection	1	1
Hypothermia	1	1
Hypoxia	1	1
Scarring	1	1
Increased Sensitivity	1	1
Swelling	1	1
Needle Stick/Puncture	1	1
No Code Available	1	1
Missing Value Reason	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1