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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device system, transport, aerobic
Product CodeJTW
Regulation Number 866.2900
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 12 12
2021 7 7
2022 5 5
2023 23 23
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 10 10
Short Fill 9 9
Device Contamination with Chemical or Other Material 7 7
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Volume Accuracy Problem 4 4
Device Markings/Labelling Problem 4 4
Device Ingredient or Reagent Problem 3 3
Delivered as Unsterile Product 3 3
Product Quality Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Separation Problem 1 1
Premature Separation 1 1
Missing Information 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Break 1 1
Contamination 1 1
Material Separation 1 1
Use of Device Problem 1 1
Material Protrusion/Extrusion 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 12 12
No Information 2 2
No Consequences Or Impact To Patient 2 2
Needle Stick/Puncture 1 1
Blood Loss 1 1
No Patient Involvement 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
Failure of Implant 1 1
Inflammation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hologic, Inc II Mar-11-2022
2 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
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