TPLC - Total Product Life Cycle

show TPLC since

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	55	55
Component Incompatible	6	6
Appropriate Device Problem Term/Code Not Available	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Material Integrity Problem	3	3
Product Quality Problem	2	2
Use of Device Problem	1	1
Protective Measures Problem	1	1
Separation Problem	1	1
Device Unsafe to Use in Environment	1	1
Detachment of Device or Device Component	1	1

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

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