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	76
Product Quality Problem	22	22
Adverse Event Without Identified Device or Use Problem	16	16
Patient-Device Incompatibility	9	9
Component Incompatible	5	5
Device Markings/Labelling Problem	5	5
Device Emits Odor	5	5
Detachment of Device or Device Component	4	4
Patient Device Interaction Problem	4	4
Defective Device	4	4
Material Puncture/Hole	3	3
Material Integrity Problem	3	3
Loose or Intermittent Connection	2	2
Inadequacy of Device Shape and/or Size	2	2
Packaging Problem	2	2
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Therapeutic or Diagnostic Output Failure	2	2
Insufficient Information	2	2
Moisture Damage	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Microbial Contamination of Device	1	1
Defective Component	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Device Fell	1	1
Device Unsafe to Use in Environment	1	1
Material Disintegration	1	1
Separation Problem	1	1
Material Split, Cut or Torn	1	1
Device-Device Incompatibility	1	1
Device Contamination with Chemical or Other Material	1	1
Protective Measures Problem	1	1
Device Reprocessing Problem	1	1
Melted	1	1
Nonstandard Device	1	1
Failure of Device to Self-Test	1	1
Material Too Soft/Flexible	1	1
Fitting Problem	1	1
Leak/Splash	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	57	57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	24	24
No Known Impact Or Consequence To Patient	21	21
Insufficient Information	15	15
Rash	9	9
Hypersensitivity/Allergic reaction	8	8
Dyspnea	8	8
Cough	7	7
Reaction	7	7
Itching Sensation	7	7
Headache	6	6
Burning Sensation	5	5
Viral Infection	5	5
Sneezing	4	4
Hot Flashes/Flushes	2	2
No Code Available	2	2
Anaphylactic Shock	2	2
Asthma	2	2
Pain	2	2
Chemical Exposure	2	2
Erythema	2	2
Swelling	2	2
No Patient Involvement	2	2
Skin Burning Sensation	1	1
Angioedema	1	1
Uveitis	1	1
Bronchitis	1	1
Sore Throat	1	1
No Consequences Or Impact To Patient	1	1
Unspecified Respiratory Problem	1	1
Nodule	1	1
Fluid Discharge	1	1
Peeling	1	1
Unspecified Eye / Vision Problem	1	1
Chest Pain	1	1
Irritation	1	1
Chest Tightness/Pressure	1	1
Local Reaction	1	1
Abrasion	1	1
Malaise	1	1
Dry Eye(s)	1	1
Skin Inflammation/ Irritation	1	1
Test Result	1	1
Dizziness	1	1
Corneal Abrasion	1	1
Emotional Changes	1	1
Tingling	1	1
Syncope/Fainting	1	1
Patient Problem/Medical Problem	1	1
Weight Changes	1	1

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