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	118	118
Detachment of Device or Device Component	88	88
Defective Device	49	49
Break	38	38
No Apparent Adverse Event	34	34
Defective Component	31	31
Manufacturing, Packaging or Shipping Problem	29	29
Fracture	19	19
Contamination	19	19
Premature Separation	11	11
Insufficient Information	11	11
Appropriate Term/Code Not Available	9	9
Leak/Splash	7	7
Entrapment of Device	7	7
Patient-Device Incompatibility	7	7
Unsealed Device Packaging	7	7
Material Separation	6	6
Device Contaminated During Manufacture or Shipping	5	5
Device Appears to Trigger Rejection	5	5
Difficult to Remove	4	4
Material Fragmentation	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
Material Integrity Problem	3	3
Use of Device Problem	2	3
Material Discolored	2	2
Device Emits Odor	2	2
Device Markings/Labelling Problem	2	2
Crack	2	2
Output Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Inaccurate Information	2	2
Fluid/Blood Leak	2	2
Device Misassembled During Manufacturing /Shipping	1	1
Missing Test Results	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
False Positive Result	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	296	296
No Known Impact Or Consequence To Patient	97	97
Hypersensitivity/Allergic reaction	91	91
Reaction	32	32
Foreign Body In Patient	30	30
Abrasion	28	28
Laceration(s)	19	19
Rash	17	17
Headache	12	12
Pain	11	11
Unspecified Infection	10	10
Cerebrospinal Fluid Leakage	10	11
Insufficient Information	10	10
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	6
Hemorrhage/Bleeding	5	5
Irritation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Tachycardia	4	4
Nasal Obstruction	4	4
Discomfort	4	4
Epistaxis	4	4
Tinnitus	3	3
Abscess	3	3
No Patient Involvement	3	3
Blood Loss	3	3
Itching Sensation	3	3
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	2
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