TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
APEX MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
FEMCAP INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
LIBRETTE, INC
	SUBSTANTIALLY EQUIVALENT	1
LUNE GROUP LTD.
	SUBSTANTIALLY EQUIVALENT	1
MELUNA
	SUBSTANTIALLY EQUIVALENT	1
MENSTRUAL MATES
	SUBSTANTIALLY EQUIVALENT	1
SCKOON INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult to Remove	261	261
Patient Device Interaction Problem	188	188
Adverse Event Without Identified Device or Use Problem	34	34
Patient-Device Incompatibility	12	12
Insufficient Information	10	10
Suction Problem	9	9
Break	8	8
Device-Device Incompatibility	6	6
Compatibility Problem	5	5
Device Dislodged or Dislocated	5	5
Appropriate Term/Code Not Available	5	5
Expulsion	4	4
Inadequate Instructions for Non-Healthcare Professional	2	2
Entrapment of Device	2	2
Migration or Expulsion of Device	2	2
Product Quality Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Improper or Incorrect Procedure or Method	2	2
Leak/Splash	1	1
Device Slipped	1	1
Fitting Problem	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Malposition of Device	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Difficult to Fold, Unfold or Collapse	1	1
Unintended Movement	1	1
Positioning Problem	1	1
Microbial Contamination of Device	1	1
Use of Device Problem	1	1
Device Handling Problem	1	1
Sticking	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	177	177
Pain	50	50
Therapeutic Effects, Unexpected	44	44
No Known Impact Or Consequence To Patient	43	43
No Clinical Signs, Symptoms or Conditions	41	41
Insufficient Information	28	28
Urinary Tract Infection	16	16
Unspecified Infection	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
No Code Available	9	9
Hypersensitivity/Allergic reaction	8	8
Abdominal Pain	7	7
Bacterial Infection	7	7
Prolapse	7	7
Fungal Infection	7	7
Discomfort	7	7
Fever	6	6
Local Reaction	6	6
Toxic Shock Syndrome	5	5
Nausea	5	5
Intermenstrual Bleeding	5	5
Unspecified Reproductive System or Breast Problem	4	4
Device Embedded In Tissue or Plaque	4	4
Laceration(s)	4	4
Menstrual Irregularities	4	4
Abnormal Vaginal Discharge	4	4
Patient Problem/Medical Problem	4	4
Rash	3	3
Tachycardia	3	3
Cyst(s)	2	2
Anemia	2	2
Genital Bleeding	2	2
Irritation	2	2
Burning Sensation	2	2
Not Applicable	2	2
Diarrhea	2	2
Hemorrhage/Bleeding	2	2
Swelling	2	2
Tissue Damage	2	2
Swelling/ Edema	2	2
Skin Irritation	2	2
Sepsis	2	2
Miscarriage	1	1
Distress	1	1
Urticaria	1	1
Thyroid Problems	1	1
Neuralgia	1	1
Low Blood Pressure/ Hypotension	1	1
Hyperemia	1	1
Abortion	1	1