TPLC - Total Product Life Cycle

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Device	pad, menstrual, unscented
Regulation Description	Unscented menstrual pad.
Definition	An unscented menstrual pad which is used to absorb menstrual fluid or other vaginal discharge and is made of common cellulosic and synthetic material with an established safety profile.
Product Code	HHD
Regulation Number	884.5435
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Emits Odor	14	25
Patient-Device Incompatibility	7	7
Patient Device Interaction Problem	6	6
Adverse Event Without Identified Device or Use Problem	5	5
Device Markings/Labelling Problem	4	4
Contamination	3	3
Product Quality Problem	3	3
Device Contaminated During Manufacture or Shipping	2	2
Use of Device Problem	2	2
Output Problem	1	1
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Contamination /Decontamination Problem	1	1
Unraveled Material	1	1
Material Discolored	1	1
Sharp Edges	1	1
Fluid/Blood Leak	1	1
Biocompatibility	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Skin Inflammation/ Irritation	20	20
Itching Sensation	15	15
Rash	10	21
No Clinical Signs, Symptoms or Conditions	10	10
Nausea	8	8
Pain	6	6
Hypersensitivity/Allergic reaction	6	6
Swelling/ Edema	5	5
Burning Sensation	5	5
Erythema	4	4
Discomfort	3	3
Sleep Dysfunction	3	14
Caustic/Chemical Burns	3	3
Urinary Frequency	2	2
Insufficient Information	2	2
Unspecified Kidney or Urinary Problem	2	2
Skin Burning Sensation	2	2
Aspiration/Inhalation	2	2
Unspecified Infection	2	2
Inflammation	2	2
Vomiting	2	2
Abdominal Pain	1	12
Local Reaction	1	1
Skin Discoloration	1	1
Urinary Tract Infection	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	12
Peeling	1	1
Skin Infection	1	1
Cramp(s) /Muscle Spasm(s)	1	12
Blister	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Tissue Injury	1	1
Reaction to Medicinal Component of Device	1	1
Respiratory Tract Infection	1	1
Foreign Body In Patient	1	1
Cancer	1	1