TPLC - Total Product Life Cycle

show TPLC since

Device	applicator, absorbent tipped, non-sterile
Regulation Description	Absorbent tipped applicator.
Product Code	KXF
Regulation Number	880.6025
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	55	55
Contamination /Decontamination Problem	28	28
Material Separation	21	21
Contamination	14	14
Defective Device	13	13
Defective Component	8	8
Manufacturing, Packaging or Shipping Problem	7	7
Device Markings/Labelling Problem	5	5
Appropriate Device Problem Term/Code Not Available	4	4
Break	4	4
Insufficient Device Problem Information	4	4
Material Fragmentation	3	3
Labelling, Instructions for Use or Training Problem	3	3
Detachment of Device or Device Component	3	3
Missing Information	2	2
No Apparent Adverse Event	2	2
Material Integrity Problem	2	2
Device Emits Odor	1	1
Loss of or Failure to Bond	1	1
Sharp Edges	1	1
Device Appears to Trigger Rejection	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	81	81
Reaction	26	26
Foreign Body In Patient	23	24
Hypersensitivity/Allergic reaction	21	21
Insufficient Information	8	8
Abrasion	6	6
Unspecified Infection	4	4
Irritation	3	3
Rash	3	3
No Known Impact Or Consequence To Patient	2	2
Ear Pain	2	2
Laceration(s)	2	2
Burn(s)	2	2
Ear infection	1	1
Airway Obstruction	1	1
Nerve Damage	1	1
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Partial Hearing Loss	1	1
Cerebrospinal Fluid Leakage	1	1
Meningitis	1	1
Discomfort	1	1
Aspiration/Inhalation	1	1
Burn, Thermal	1	1
Unspecified Ear or Labyrinth Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Avanos Medical, Inc.	II	Apr-19-2023