TPLC - Total Product Life Cycle

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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	59	59
Contamination /Decontamination Problem	28	28
Contamination	15	15
Defective Device	14	14
Material Separation	13	13
Break	9	10
Defective Component	8	8
Detachment of Device or Device Component	8	8
Device Markings/Labelling Problem	5	5
Insufficient Information	4	4
Device Fell	4	4
Material Fragmentation	4	4
Labelling, Instructions for Use or Training Problem	3	3
Appropriate Term/Code Not Available	3	3
Manufacturing, Packaging or Shipping Problem	2	2
No Apparent Adverse Event	2	2
Missing Information	2	2
Disconnection	1	1
Device Slipped	1	1
Separation Problem	1	1
Burst Container or Vessel	1	1
Entrapment of Device	1	1
Fire	1	1
Output Problem	1	1
Material Integrity Problem	1	1
Particulates	1	1
Sharp Edges	1	1
Device Emits Odor	1	1
Residue After Decontamination	1	1
Device Contamination with Chemical or Other Material	1	1
Device Appears to Trigger Rejection	1	1
Inaccurate Information	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	70	70
Reaction	26	26
Hypersensitivity/Allergic reaction	21	21
Foreign Body In Patient	21	22
Insufficient Information	7	7
Abrasion	6	6
Unspecified Infection	4	4
Irritation	3	3
Rash	3	3
No Known Impact Or Consequence To Patient	2	2
Burn(s)	2	2
Laceration(s)	2	2
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Aspiration/Inhalation	1	1
Burn, Thermal	1	1
Unspecified Ear or Labyrinth Problem	1	1
Nerve Damage	1	1
Discomfort	1	1
Partial Hearing Loss	1	1
Cerebrospinal Fluid Leakage	1	1
Meningitis	1	1
Airway Obstruction	1	1

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