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	62	63
Product Quality Problem	11	13
Component Incompatible	6	6
Patient-Device Incompatibility	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Appropriate Term/Code Not Available	5	5
Defective Device	4	4
Device Emits Odor	4	5
Detachment of Device or Device Component	4	6
Device Markings/Labelling Problem	3	3
Material Integrity Problem	3	3
Patient Device Interaction Problem	3	3
Use of Device Problem	2	2
Nonstandard Device	2	2
Leak/Splash	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Insufficient Information	1	1
Device Fell	1	1
Therapeutic or Diagnostic Output Failure	1	1
Structural Problem	1	1
Device Unsafe to Use in Environment	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Contamination with Chemical or Other Material	1	1
Protective Measures Problem	1	1
Device Reprocessing Problem	1	1
Melted	1	1
Material Too Soft/Flexible	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	56	56
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	29	29
Insufficient Information	13	16
Hypersensitivity/Allergic reaction	8	9
Itching Sensation	4	4
Rash	4	5
Viral Infection	4	4
Skin Inflammation/ Irritation	3	3
Burning Sensation	3	3
Hot Flashes/Flushes	3	3
Pain	2	3
Anaphylactic Shock	2	2
Swelling/ Edema	2	2
Corneal Clouding/Hazing	1	2
Urticaria	1	1
Weight Changes	1	2
Syncope/Fainting	1	2
Emotional Changes	1	2
Corneal Abrasion	1	1
Dry Eye(s)	1	2
Malaise	1	2
Abrasion	1	1
Asthma	1	1
Local Reaction	1	1
Chemical Exposure	1	2
Chest Pain	1	1
Erythema	1	1
Unspecified Eye / Vision Problem	1	2
Dyspnea	1	1
Peeling	1	1
Nodule	1	1
Unspecified Respiratory Problem	1	2
Headache	1	1
Bronchitis	1	1
Uveitis	1	2
Angioedema	1	1
Skin Burning Sensation	1	1

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