TPLC - Total Product Life Cycle

show TPLC since

Device	tampon, menstrual, scented, deodorized
Product Code	HIL
Regulation Number	884.5460
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	18	18
Adverse Event Without Identified Device or Use Problem	11	11
No Apparent Adverse Event	6	6
Material Separation	3	3
Patient-Device Incompatibility	2	2
Compatibility Problem	1	1
Entrapment of Device	1	1
Device Contamination with Body Fluid	1	1
Malposition of Device	1	1
Defective Component	1	1
Degraded	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Device Operates Differently Than Expected	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Foreign Body In Patient	13	13
Toxic Shock Syndrome	9	9
Device Embedded In Tissue or Plaque	5	5
No Clinical Signs, Symptoms or Conditions	4	4
Discomfort	3	3
Unspecified Infection	2	2
Fever	2	2
Rash	2	2
Vomiting	2	2
Pain	2	2
Bacterial Infection	2	2
No Consequences Or Impact To Patient	2	2
Abdominal Pain	1	1
Menstrual Irregularities	1	1
Patient Problem/Medical Problem	1	1
Hypersensitivity/Allergic reaction	1	1
Sepsis	1	1
Abnormal Vaginal Discharge	1	1
Disability	1	1
Skin Inflammation/ Irritation	1	1
Malaise	1	1
Abrasion	1	1
Itching Sensation	1	1
Local Reaction	1	1
Confusion/ Disorientation	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
Chills	1	1
Injury	1	1
Diarrhea	1	1
Erythema	1	1
Hair Loss	1	1
Coma	1	1
Anxiety	1	1
Headache	1	1
Loss of Vision	1	1
Loss of consciousness	1	1
Deafness	1	1