TPLC - Total Product Life Cycle

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Device	applicator, absorbent tipped, non-sterile
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	71	71
Contamination /Decontamination Problem	62	62
Defective Device	19	19
Contamination	15	15
Material Separation	14	14
Break	13	13
Defective Component	10	10
Detachment of Device or Device Component	8	8
Device Markings/Labelling Problem	5	5
Insufficient Information	4	4
Device Fell	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Appropriate Term/Code Not Available	3	3
Missing Information	3	3
Labelling, Instructions for Use or Training Problem	3	3
Packaging Problem	3	3
No Apparent Adverse Event	2	2
Patient-Device Incompatibility	2	2
Material Fragmentation	2	2
Fluid/Blood Leak	1	1
Loss of or Failure to Bond	1	1
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Inaccurate Information	1	1
Device Appears to Trigger Rejection	1	1
Illegible Information	1	1
Device Contamination with Chemical or Other Material	1	1
Residue After Decontamination	1	1
Product Quality Problem	1	1
Device Emits Odor	1	1
Sharp Edges	1	1
Material Perforation	1	1
Particulates	1	1
Use of Device Problem	1	1
Patient Device Interaction Problem	1	1
Difficult to Remove	1	1
Material Integrity Problem	1	1
Physical Resistance/Sticking	1	1
Output Problem	1	1
Malposition of Device	1	1
Fire	1	1
Entrapment of Device	1	1
Burst Container or Vessel	1	1
Separation Problem	1	1
Device Ingredient or Reagent Problem	1	1
Device Slipped	1	1
Leak/Splash	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	74	74
No Known Impact Or Consequence To Patient	48	48
Reaction	34	34
Hypersensitivity/Allergic reaction	22	22
Foreign Body In Patient	21	21
Insufficient Information	7	7
Unspecified Infection	6	6
Abrasion	6	6
Rash	4	4
Laceration(s)	4	4
Not Applicable	3	3
Irritation	3	3
Pain	3	3
Burn(s)	2	2
Burning Sensation	2	2
No Consequences Or Impact To Patient	2	2
Hearing Impairment	1	1
Impaired Healing	1	1
Patient Problem/Medical Problem	1	1
Fatigue	1	1
Hearing Loss	1	1
Nausea	1	1
Skin Irritation	1	1
Respiratory Arrest	1	1
Skin Inflammation/ Irritation	1	1
Malaise	1	1
Rupture	1	1
Burn, Thermal	1	1
Blood Loss	1	1
Needle Stick/Puncture	1	1
Nerve Damage	1	1
Cerebrospinal Fluid Leakage	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
Tinnitus	1	1
Meningitis	1	1
Airway Obstruction	1	1

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