Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device decontamination systems for n95 respirators
Definition Device intended to decontaminate compatible N95 or N95-equivalent respirators for their reuse by healthcare professionals during the declared public health emergency.
Product CodeQKY
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 202 202
2021 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 116 116
Contamination 41 41
Device Emits Odor 37 37
Break 33 33
Material Too Soft/Flexible 19 19
Insufficient Information 18 18
No Apparent Adverse Event 14 14
Fluid/Blood Leak 13 13
Stretched 11 11
Peeled/Delaminated 5 5
Device Reprocessing Problem 5 5
Degraded 4 4
Material Frayed 3 3
Leak/Splash 3 3
Defective Device 3 3
Material Deformation 3 3
Fumes or Vapors 2 2
Material Discolored 2 2
Dent in Material 2 2
Environmental Particulates 2 2
Material Opacification 1 1
Unintended Electrical Shock 1 1
Material Puncture/Hole 1 1
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Problem with Sterilization 1 1
Moisture or Humidity Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 147 147
Viral Infection 33 33
Cough 29 29
Burning Sensation 29 29
Skin Inflammation/ Irritation 25 25
Headache 24 24
Sore Throat 23 23
Nasal Obstruction 20 20
Dyspnea 19 19
Rash 15 15
Nausea 9 9
Fatigue 9 9
Itching Sensation 9 9
Discomfort 9 9
Skin Discoloration 9 9
Dizziness 7 7
Sneezing 6 6
Hypersensitivity/Allergic reaction 6 6
Diarrhea 5 5
No Patient Involvement 5 5
Fever 5 5
Chills 5 5
Eye Pain 4 4
Swelling/ Edema 3 3
Chest Pain 3 3
Insufficient Information 3 3
Burn(s) 3 3
Confusion/ Disorientation 3 3
Skin Disorders 3 3
Chemical Exposure 3 3
Asthma 2 2
Caustic/Chemical Burns 2 2
Unspecified Respiratory Problem 2 2
Ageusia 2 2
Cellulitis 1 1
Neck Pain 1 1
Epistaxis 1 1
Erythema 1 1
No Known Impact Or Consequence To Patient 1 1
Vomiting 1 1
Numbness 1 1
Blister 1 1
Eye Burn 1 1
Cognitive Changes 1 1
Localized Skin Lesion 1 1
Virus 1 1
Electric Shock 1 1
Skin Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Battelle Memorial Institute II Oct-29-2020
-
-