TPLC - Total Product Life Cycle

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Device	respirator, surgical
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

Premarket Reviews
Manufacturer	Decision
3M COMPANY
	SUBSTANTIALLY EQUIVALENT	1
3M HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	1
ALPHAPROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
MASTER & FRANK ENTERPRISE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MOLDEX/METRIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
MOLNLYCKE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
OWENS & MINOR (O&M) HALYARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
PASTURE PHARMA PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
PRESTIGE AMERITECH
	SUBSTANTIALLY EQUIVALENT	1
SAFELIFE CORP.
	SUBSTANTIALLY EQUIVALENT	1
SAN-M PACKAGE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI DASHENG HEALTH PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1

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	19	19
Patient-Device Incompatibility	11	11
Device Markings/Labelling Problem	5	5
Device Emits Odor	5	5
Component Incompatible	5	5
Detachment of Device or Device Component	4	4
Defective Device	4	4
Patient Device Interaction Problem	4	4
Material Integrity Problem	3	3
Material Puncture/Hole	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Inadequacy of Device Shape and/or Size	2	2
Loose or Intermittent Connection	2	2
Packaging Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fitting Problem	2	2
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Material Too Soft/Flexible	1	1
Material Split, Cut or Torn	1	1
Device Fell	1	1
Separation Problem	1	1
Defective Component	1	1
Microbial Contamination of Device	1	1
Structural Problem	1	1
Device-Device Incompatibility	1	1
Failure of Device to Self-Test	1	1
Device Contamination with Chemical or Other Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
No Apparent Adverse Event	1	1
Protective Measures Problem	1	1
Melted	1	1
Moisture Damage	1	1
Nonstandard Device	1	1
Material Disintegration	1	1
Fluid/Blood Leak	1	1
Leak/Splash	1	1
Smoking	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Device Reprocessing Problem	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, Conditions Term / Code Not Available	23	23
No Known Impact Or Consequence To Patient	23	23
Insufficient Information	15	15
Rash	10	10
Hypersensitivity/Allergic reaction	8	8
Dyspnea	8	8
Itching Sensation	8	8
Reaction	8	8
Cough	7	7
Burning Sensation	6	6
Headache	6	6
Viral Infection	5	5
Sneezing	5	5
No Code Available	4	4
Sore Throat	3	3
Patient Problem/Medical Problem	3	3
Anaphylactic Shock	3	3
Asthma	2	2
Erythema	2	2
Chemical Exposure	2	2
Hot Flashes/Flushes	2	2
Pain	2	2
Swelling	2	2
No Patient Involvement	2	2
Fluid Discharge	1	1
Syncope/Fainting	1	1
Test Result	1	1
Unspecified Respiratory Problem	1	1
Unspecified Eye / Vision Problem	1	1
Angioedema	1	1
Skin Burning Sensation	1	1
Skin Inflammation/ Irritation	1	1
Nodule	1	1
Uveitis	1	1
Peeling	1	1
Tingling	1	1
Dizziness	1	1
No Consequences Or Impact To Patient	1	1
Weight Changes	1	1
Chest Tightness/Pressure	1	1
Urticaria	1	1
Malaise	1	1
Corneal Clouding/Hazing	1	1
Emotional Changes	1	1
Bronchitis	1	1
Chest Pain	1	1
Corneal Abrasion	1	1
Dry Eye(s)	1	1
Abrasion	1	1
High Blood Pressure/ Hypertension	1	1
Irritation	1	1
Local Reaction	1	1
Respiratory Distress	1	1
Skin Irritation	1	1