TPLC - Total Product Life Cycle

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Device	gauze / sponge,nonresorbable for external use
Regulation Description	Nonresorbable gauze/sponge 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	17	17
Material Integrity Problem	7	7
Contamination /Decontamination Problem	4	4
Material Frayed	3	3
Material Discolored	3	3
Break	2	2
Patient-Device Incompatibility	2	2
Contamination	2	2
Patient Device Interaction Problem	2	2
Material Fragmentation	2	2
Packaging Problem	2	2
Product Quality Problem	2	2
Flaked	2	2
Loose or Intermittent Connection	2	2
Device Contaminated During Manufacture or Shipping	1	1
Output Problem	1	1
Insufficient Information	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Microbial Contamination of Device	1	1
Device Difficult to Setup or Prepare	1	1
Component Missing	1	1
Appropriate Term/Code Not Available	1	1
Component Incompatible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	21	21
Skin Inflammation/ Irritation	13	13
Skin Infection	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Hypersensitivity/Allergic reaction	6	6
Insufficient Information	6	6
Impaired Healing	5	5
Rash	5	5
Foreign Body In Patient	3	3
Blister	2	2
Pain	2	2
Swelling/ Edema	2	2
Intracranial Hemorrhage	1	1
Bradycardia	1	1
Caustic/Chemical Burns	1	1
Respiratory Failure	1	1