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

MDR Year	MDR Reports	MDR Events
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	27	27
Product Quality Problem	7	7
Patient-Device Incompatibility	5	5
Insufficient Information	5	5
Appropriate Term/Code Not Available	1	1
Failure To Adhere Or Bond	1	1
Material Integrity Problem	1	1
Failure to Obtain Sample	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Swelling	6	6
Convulsion/Seizure	5	5
Burning Sensation	4	4
Abrasion	4	4
Hypersensitivity/Allergic reaction	4	4
Pain	4	4
Rash	4	4
Seizures	4	4
Skin Discoloration	3	3
Unspecified Infection	3	3
Dyspnea	3	3
Skin Irritation	3	3
Deformity/ Disfigurement	3	3
Skin Tears	3	3
Cancer	3	3
No Code Available	2	2
Skin Inflammation/ Irritation	2	2
Swelling/ Edema	2	2
Chest Tightness/Pressure	2	2
Choking	2	2
Itching Sensation	2	2
Anxiety	2	2
Emotional Changes	2	2
Erythema	2	2
Anaphylactic Shock	2	2
Bruise/Contusion	2	2
Cellulitis	2	2
Corneal Abrasion	1	1
Dry Eye(s)	1	1
Dysphagia/ Odynophagia	1	1
Headache	1	1
Irritation	1	1
Peeling	1	1
Skin Erosion	1	1
Local Reaction	1	1
Respiratory Distress	1	1
Wheal(s)	1	1
Skull Fracture	1	1
Tissue Damage	1	1
Visual Impairment	1	1
Reaction	1	1
Sleep Dysfunction	1	1
Blood Loss	1	1
Hemorrhage, Subgaleal	1	1
Partial thickness (Second Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Contact Dermatitis	1	1
Blister	1	1
Skin Burning Sensation	1	1
Localized Skin Lesion	1	1