TPLC - Total Product Life Cycle

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Device	gauze / sponge,nonresorbable for external use
Product Code	NAB
Regulation Number	878.4014
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	38	38
Material Integrity Problem	6	6
Material Fragmentation	6	6
Contamination /Decontamination Problem	6	6
Material Separation	5	5
Material Frayed	5	5
Contamination	3	3
Material Discolored	2	2
Break	2	2
Flaked	2	2
Loose or Intermittent Connection	2	2
Delivered as Unsterile Product	2	2
Product Quality Problem	2	2
Packaging Problem	2	2
Insufficient Information	1	1
Device Fell	1	1
Output Problem	1	1
Device Difficult to Setup or Prepare	1	1
Knotted	1	1
Fire	1	1
Use of Device Problem	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1
Patient-Device Incompatibility	1	1
Device Operates Differently Than Expected	1	1
Incorrect Device Or Component Shipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Deformation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	14	14
No Known Impact Or Consequence To Patient	11	11
No Clinical Signs, Symptoms or Conditions	11	11
Skin Inflammation/ Irritation	10	10
Reaction	8	8
Itching Sensation	7	7
Skin Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
No Consequences Or Impact To Patient	6	6
No Patient Involvement	6	6
Peeling	5	5
Hypersensitivity/Allergic reaction	5	5
Unspecified Infection	5	5
Insufficient Information	5	5
Impaired Healing	4	4
No Code Available	3	3
Death	3	3
Rash	3	3
Foreign Body In Patient	3	3
Swelling	3	3
Burn(s)	2	2
No Information	2	2
Swelling/ Edema	2	2
Blister	1	1
Unintended Radiation Exposure	1	1
Skin Irritation	1	1
Injury	1	1
Skin Tears	1	1
Caustic/Chemical Burns	1	1