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	31	31
Contamination /Decontamination Problem	7	7
Material Integrity Problem	6	6
Material Fragmentation	6	6
Material Frayed	3	3
Contamination	3	3
Break	2	2
Material Discolored	2	2
Product Quality Problem	2	2
Material Separation	2	2
Flaked	2	2
Loose or Intermittent Connection	2	2
Fire	1	1
Output Problem	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Device Fell	1	1
Microbial Contamination of Device	1	1
Device Difficult to Setup or Prepare	1	1
Use of Device Problem	1	1
Packaging Problem	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	15	15
Pain	13	13
Skin Inflammation/ Irritation	11	11
Skin Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Hypersensitivity/Allergic reaction	6	6
Itching Sensation	6	6
Insufficient Information	6	6
No Consequences Or Impact To Patient	6	6
Impaired Healing	5	5
No Known Impact Or Consequence To Patient	5	5
Reaction	5	5
Peeling	4	4
Rash	3	3
Swelling	3	3
No Code Available	2	2
Blister	2	2
Foreign Body In Patient	2	2
Swelling/ Edema	2	2
Unspecified Infection	1	1
Skin Irritation	1	1
Burn(s)	1	1
Injury	1	1
No Patient Involvement	1	1
Caustic/Chemical Burns	1	1
Unintended Radiation Exposure	1	1