TPLC - Total Product Life Cycle

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Device	respirator, surgical
Regulation Description	Surgical apparel.
Definition	A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures subject to 21 CFR 878.9 and the conditions for exemption identified in 21 CFR 878.4040(b)(1).
Product Code	MSH
Regulation Number	878.4040
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	76	78
Product Quality Problem	22	26
Adverse Event Without Identified Device or Use Problem	16	16
Patient-Device Incompatibility	9	10
Component Incompatible	6	6
Appropriate Term/Code Not Available	5	5
Device Markings/Labelling Problem	5	5
Device Emits Odor	5	26
Patient Device Interaction Problem	5	5
Detachment of Device or Device Component	4	6
Defective Device	4	4
Material Puncture/Hole	3	4
Material Integrity Problem	3	3
Loose or Intermittent Connection	2	2
Nonstandard Device	2	2
Inadequacy of Device Shape and/or Size	2	11
Packaging Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	22
Therapeutic or Diagnostic Output Failure	2	11
Insufficient Information	2	3
Moisture Damage	1	1
Microbial Contamination of Device	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	6
Device Unsafe to Use in Environment	1	1
Defective Component	1	1
Device Fell	1	1
Material Disintegration	1	1
Separation Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Protective Measures Problem	1	1
Material Split, Cut or Torn	1	1
Device Reprocessing Problem	1	1
Melted	1	1
Device-Device Incompatibility	1	1
Failure of Device to Self-Test	1	1
Material Too Soft/Flexible	1	1
Fitting Problem	1	12
Leak/Splash	1	1
Improper or Incorrect Procedure or Method	1	2
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
No Known Impact Or Consequence To Patient	21	51
Insufficient Information	16	19
Hypersensitivity/Allergic reaction	9	10
Rash	9	10
Dyspnea	8	9
Cough	7	8
Reaction	7	8
Itching Sensation	7	7
Headache	6	6
Viral Infection	5	5
Burning Sensation	5	6
Sneezing	4	5
Hot Flashes/Flushes	2	2
Anaphylactic Shock	2	2
Pain	2	3
No Patient Involvement	2	9
Swelling	2	2
Erythema	2	2
Chemical Exposure	2	3
Asthma	2	2
Skin Inflammation/ Irritation	2	2
No Code Available	2	2
Local Reaction	1	1
Chest Tightness/Pressure	1	1
Abrasion	1	1
Irritation	1	1
Malaise	1	2
Dry Eye(s)	1	2
Chest Pain	1	1
Test Result	1	1
Dizziness	1	1
Corneal Abrasion	1	1
Unspecified Eye / Vision Problem	1	2
Emotional Changes	1	2
Tingling	1	1
Peeling	1	1
Syncope/Fainting	1	2
Fluid Discharge	1	1
Patient Problem/Medical Problem	1	1
Weight Changes	1	2
Nodule	1	1
Swelling/ Edema	1	1
Unspecified Respiratory Problem	1	2
Urticaria	1	1
Corneal Clouding/Hazing	1	2
No Consequences Or Impact To Patient	1	1
Sore Throat	1	1
Bronchitis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	O&M HALYARD, INC.	II	Sep-21-2023