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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stand, infusion
Product CodeFOX
Regulation Number 880.6990
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 2 2
2017 8 8
2018 17 17
2019 23 23
2020 112 112
2021 173 173
2022 12 12
2023 3 3
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 119 119
Misconnection 72 72
Loss of or Failure to Bond 37 37
Adverse Event Without Identified Device or Use Problem 19 19
Disconnection 16 16
Material Twisted/Bent 16 16
Difficult to Open or Close 16 16
Break 13 13
Loose or Intermittent Connection 9 9
Defective Component 9 9
Malposition of Device 8 8
Contamination /Decontamination Problem 8 8
Mechanical Problem 5 5
Material Separation 5 5
Detachment Of Device Component 5 5
Crack 5 5
Product Quality Problem 4 4
Difficult to Remove 4 4
Fluid/Blood Leak 4 4
Device Tipped Over 3 3
Patient-Device Incompatibility 3 3
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Component Falling 3 3
Component Missing 3 3
Therapeutic or Diagnostic Output Failure 3 3
Defective Device 3 3
Degraded 2 2
Material Deformation 2 2
Contamination of Device Ingredient or Reagent 1 1
Failure To Run On AC/DC 1 1
Activation Failure 1 1
Incorrect Measurement 1 1
Device Contamination with Chemical or Other Material 1 1
Unintended Collision 1 1
Improper or Incorrect Procedure or Method 1 1
Unintended Arm Motion 1 1
Connection Problem 1 1
Electromagnetic Interference 1 1
Device Operates Differently Than Expected 1 1
Appropriate Term/Code Not Available 1 1
Material Integrity Problem 1 1
Smoking 1 1
Positioning Problem 1 1
Unsealed Device Packaging 1 1
Electromagnetic Compatibility Problem 1 1
Delivered as Unsterile Product 1 1
Infusion or Flow Problem 1 1
Structural Problem 1 1
Device Difficult to Setup or Prepare 1 1
Shipping Damage or Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 163 163
No Consequences Or Impact To Patient 140 140
No Known Impact Or Consequence To Patient 20 20
No Patient Involvement 10 10
Ulcer 9 9
Insufficient Information 6 6
Erythema 4 4
Foreign Body Reaction 3 3
Skin Irritation 2 2
No Information 2 2
Unspecified Infection 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
Tingling 1 1
Complaint, Ill-Defined 1 1
Electric Shock 1 1
Skin Inflammation/ Irritation 1 1
Head Injury 1 1
Inflammation 1 1
Abrasion 1 1
Purulent Discharge 1 1
Itching Sensation 1 1
No Patient involvement 1 1
Blister 1 1
Injury 1 1
Foreign Body In Patient 1 1
Swelling 1 1
Laceration(s) 1 1
Physical Entrapment 1 1
Reaction 1 1
Contact Dermatitis 1 1
Skin Tears 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EKOS Corporation II Sep-27-2016
2 Firefly Medical, Inc. II Sep-07-2017
3 Firefly Medical, Inc. II Dec-15-2016
4 Ohmeda Medical II Mar-26-2018
5 Stryker Medical Division of Stryker Corporation II Nov-30-2015
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