TPLC - Total Product Life Cycle

• Device: dilator, nasal
• Product Code: LWF
• Regulation Number: 874.3900
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
CPAPNEA MEDICAL SUPPLY
	SUBSTANTIALLY EQUIVALENT	1
VENTUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	12	12
2015	41	41
2016	39	39
2017	13	13
2018	15	15
2019	13	13
2020	6	6
2021	4	4
2022	5	5
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	82	82
Insufficient Information	19	19
Patient-Device Incompatibility	14	14
Device Operates Differently Than Expected	11	11
Failure to Obtain Sample	11	11
Product Quality Problem	7	7
Appropriate Term/Code Not Available	4	4
Unexpected Therapeutic Results	3	3
Improper or Incorrect Procedure or Method	2	2
Failure To Adhere Or Bond	2	2
Material Integrity Problem	2	2
Unintended Movement	1	1
Missing Value Reason	1	1
Detachment Of Device Component	1	1
Inadequate Storage	1	1
Invalid Sensing	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Abrasion	53	53
Skin Irritation	15	15
Cancer	12	12
Swelling	11	11
Burning Sensation	11	11
Hypersensitivity/Allergic reaction	11	11
Bruise/Contusion	10	10
Erythema	10	10
Pain	8	8
Reaction	8	8
Skin Tears	6	6
Hemorrhage/Bleeding	6	6
Unspecified Infection	6	6
Rash	6	6
Scar Tissue	5	5
Irritation	5	5
Convulsion/Seizure	5	5
No Code Available	5	5
Deformity/ Disfigurement	4	4
Tissue Damage	4	4
Itching Sensation	4	4
Dyspnea	4	4
Seizures	4	4
Skin Discoloration	3	3
Local Reaction	3	3
Peeling	3	3
Anaphylactic Shock	3	3
Complaint, Ill-Defined	3	3
Sleep Dysfunction	3	3
Swelling/ Edema	2	2
Chest Tightness/Pressure	2	2
Choking	2	2
Skin Inflammation/ Irritation	2	2
Ulcer	2	2
Anxiety	2	2
Therapeutic Effects, Unexpected	2	2
Cellulitis	2	2
Death	2	2
Purulent Discharge	2	2
Emotional Changes	2	2
Laceration(s)	1	1
Nausea	1	1
Respiratory Distress	1	1
Scarring	1	1
Skin Erosion	1	1
Increased Sensitivity	1	1
Dry Eye(s)	1	1
Dysphagia/ Odynophagia	1	1
Diarrhea	1	1
Eye Injury	1	1
Headache	1	1
Hematoma	1	1
Stroke/CVA	1	1
Corneal Abrasion	1	1
Bacterial Infection	1	1
Erosion	1	1
Skull Fracture	1	1
Dizziness	1	1
Anaphylactoid	1	1
Wheal(s)	1	1
Visual Impairment	1	1
Injury	1	1
Contact Dermatitis	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Blood Loss	1	1
Hemorrhage, Subgaleal	1	1
Weight Changes	1	1
Tissue Breakdown	1	1
Partial thickness (Second Degree) Burn	1	1
Blister	1	1
Skin Burning Sensation	1	1
Localized Skin Lesion	1	1