TPLC - Total Product Life Cycle

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Device	powered microneedle device
Definition	A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Product Code	QAI
Regulation Number	878.4430
Device Class	2

Premarket Reviews
Manufacturer	Decision
CROWN AESTHETICS
	SUBSTANTIALLY EQUIVALENT	3
CYTRELLIS BIOSYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP LLC
	SUBSTANTIALLY EQUIVALENT	1
ECLIPSE MEDCORP, LLC
	SUBSTANTIALLY EQUIVALENT	1
EQUIPMED USA LLC
	SUBSTANTIALLY EQUIVALENT	1
ESTHETIC EDUCATION LLC
	SUBSTANTIALLY EQUIVALENT	1
ESTHETIC MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INDUCTION THERAPIES LLC
	SUBSTANTIALLY EQUIVALENT	1
MT. DERM GMBH
	SUBSTANTIALLY EQUIVALENT	1
MT.DERM GMBH
	SUBSTANTIALLY EQUIVALENT	1
REFINE USA LLC
	SUBSTANTIALLY EQUIVALENT	1
VENUS CONCEPT USA INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	14	14
Loss of or Failure to Bond	12	12
Material Integrity Problem	11	11
Break	11	11
Inadequate Instructions for Non-Healthcare Professional	2	2
Off-Label Use	2	2
Improper or Incorrect Procedure or Method	2	2
Use of Device Problem	1	1
Product Quality Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Missing Information	1	1
Protective Measures Problem	1	1
Unexpected Therapeutic Results	1	1
Patient-Device Incompatibility	1	1
Unclear Information	1	1
Insufficient Information	1	1
Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	11	11
Skin Discoloration	8	8
Impaired Healing	5	5
Scar Tissue	5	5
Skin Infection	3	3
Pain	3	3
Swelling/ Edema	3	3
Hemorrhage/Bleeding	3	3
Erythema	2	2
Unspecified Tissue Injury	2	2
Skin Tears	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Fatigue	1	1
Skin Inflammation/ Irritation	1	1
Cyst(s)	1	1
Localized Skin Lesion	1	1
Anaphylactoid	1	1
Oversedation	1	1
Rash	1	1
Insufficient Information	1	1
Viral Infection	1	1
Fluid Discharge	1	1
Wrinkling	1	1
Contact Dermatitis	1	1
Deformity/ Disfigurement	1	1
Low Oxygen Saturation	1	1
Granuloma	1	1
Bruise/Contusion	1	1
Skin Burning Sensation	1	1
Ambulation Difficulties	1	1