TPLC - Total Product Life Cycle

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Device	applicator, absorbent tipped, sterile
Regulation Description	Absorbent tipped applicator.
Product Code	KXG
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	223	223
Contamination /Decontamination Problem	119	119
Detachment of Device or Device Component	88	96
Defective Device	49	49
Break	39	47
No Apparent Adverse Event	34	34
Defective Component	32	32
Manufacturing, Packaging or Shipping Problem	29	29
Fracture	19	19
Contamination	19	19
Premature Separation	11	11
Insufficient Information	11	11
Incorrect, Inadequate or Imprecise Result or Readings	10	10
Appropriate Term/Code Not Available	9	9
Leak/Splash	7	7
Entrapment of Device	7	15
Patient-Device Incompatibility	7	8
Unsealed Device Packaging	7	7
Material Separation	6	6
Device Contaminated During Manufacture or Shipping	5	5
Device Appears to Trigger Rejection	5	5
Material Integrity Problem	5	5
Material Fragmentation	5	5
Difficult to Remove	4	4
Missing Information	3	3
Product Quality Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Sharp Edges	3	3
Component Missing	3	3
Patient Device Interaction Problem	3	3
Use of Device Problem	2	3
Material Discolored	2	2
Device Emits Odor	2	16
Device Markings/Labelling Problem	2	2
Crack	2	2
Output Problem	2	4
Coagulation in Device or Device Ingredient	2	2
Inaccurate Information	2	2
Fluid/Blood Leak	2	2
Missing Test Results	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Ejection Problem	1	1
Microbial Contamination of Device	1	1
Device Fell	1	1
Device Contamination with Chemical or Other Material	1	1
Separation Failure	1	1
Device Dislodged or Dislocated	1	1
False Negative Result	1	1
Optical Discoloration	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	307	315
No Known Impact Or Consequence To Patient	97	97
Hypersensitivity/Allergic reaction	91	92
Foreign Body In Patient	33	41
Reaction	32	32
Abrasion	28	28
Laceration(s)	19	19
Rash	17	17
Headache	13	13
Pain	12	12
Unspecified Infection	10	10
Cerebrospinal Fluid Leakage	10	11
Insufficient Information	10	12
Device Embedded In Tissue or Plaque	8	8
Skin Inflammation/ Irritation	8	8
Not Applicable	7	7
No Code Available	7	7
Contact Dermatitis	6	6
Burning Sensation	6	20
Hemorrhage/Bleeding	5	5
Irritation	5	5
Tinnitus	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Tachycardia	4	5
Nasal Obstruction	4	4
Discomfort	4	4
Epistaxis	4	4
Abscess	3	3
No Patient Involvement	3	3
Blood Loss	3	3
Itching Sensation	3	4
Head Injury	3	3
Nausea	3	3
Local Reaction	2	2
Taste Disorder	2	2
Abdominal Pain	2	2
Skin Discoloration	2	2
Fever	2	2
Bowel Perforation	2	2
No Consequences Or Impact To Patient	2	2
Dizziness	2	3
Skull Fracture	2	3
Encephalocele	2	2
Swelling/ Edema	2	2
Skin Irritation	2	2
Excessive Tear Production	1	1
Respiratory Failure	1	1
Premature Labor	1	1
Ventilator Dependent	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Copan Italia	II	Sep-09-2021
2	LumiraDx	II	Jun-15-2023
3	Mckesson Medical-Surgical Inc. Corporate Office	II	Aug-26-2022
4	Merit Medical Systems, Inc.	II	Nov-16-2020
5	Puritan Medical Products Company, Llc	II	Mar-28-2024
6	Stradis Medical, LLC dba Stradis Healthcare	II	Dec-14-2022