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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aid, transfer
Product CodeIKX
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2014 833 833
2015 39 39
2016 17 17
2017 16 16
2018 15 15
2019 14 14
2020 11 11
2021 5 5
2022 50 50
2023 12 12
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 308 308
Crack 198 198
Unstable 116 116
Bent 90 90
Device Slipped 54 54
Detachment Of Device Component 41 41
Product Quality Problem 35 35
Device Operates Differently Than Expected 30 30
Use of Device Problem 21 21
Torn Material 17 17
Collapse 16 16
Deformation Due to Compressive Stress 15 15
Adverse Event Without Identified Device or Use Problem 12 12
Unintended Movement 11 11
Detachment of Device or Device Component 11 11
Loose or Intermittent Connection 11 11
Mechanical Problem 11 11
Material Separation 10 10
Insufficient Information 9 9
Naturally Worn 8 8
Component Missing 7 7
Out-Of-Box Failure 6 6
Device Inoperable 6 6
Material Integrity Problem 5 5
Mechanical Jam 4 4
Split 4 4
Off-Label Use 4 4
Unraveled Material 4 4
Fracture 4 4
Inadequate or Insufficient Training 3 3
Patient-Device Incompatibility 3 3
Mechanics Altered 3 3
Human Factors Issue 2 2
Device Tipped Over 2 2
Connection Problem 2 2
Device Handling Problem 2 2
Material Split, Cut or Torn 2 2
Improper or Incorrect Procedure or Method 2 2
Device Damaged Prior to Use 2 2
Defective Component 2 2
Solder Joint Fracture 2 2
Device Issue 2 2
Failure to Align 2 2
Component Falling 2 2
Misassembled 2 2
Material Frayed 2 2
Hole In Material 2 2
Entrapment of Device 2 2
Fail-Safe Design Failure 1 1
Fluid/Blood Leak 1 1
Difficult to Fold, Unfold or Collapse 1 1
Loss of or Failure to Bond 1 1
Corroded 1 1
Material Fragmentation 1 1
Incomplete or Missing Packaging 1 1
Suction Problem 1 1
Fitting Problem 1 1
Physical Resistance/Sticking 1 1
Device Fell 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Physical Property Issue 1 1
Appropriate Term/Code Not Available 1 1
Fail-Safe Problem 1 1
Incorrect Device Or Component Shipped 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture or Humidity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 615 615
No Known Impact Or Consequence To Patient 165 165
Fall 87 87
No Clinical Signs, Symptoms or Conditions 52 52
Injury 20 20
No Information 18 18
No Patient Involvement 15 15
Laceration(s) 12 12
Bruise/Contusion 12 12
Pain 9 9
Abrasion 8 8
Bone Fracture(s) 8 8
Death 7 7
Discomfort 7 7
Physical Entrapment 6 6
Skin Tears 4 4
Patient Problem/Medical Problem 3 3
Insufficient Information 3 3
Strangulation 3 3
Hip Fracture 3 3
Fracture, Arm 3 3
Pyrosis/Heartburn 2 2
No Code Available 2 2
Blood Loss 2 2
Tissue Breakdown 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Coagulation Disorder 1 1
Joint Dislocation 1 1
Tooth Fracture 1 1
Neck Pain 1 1
Suture Abrasion 1 1
Ulceration 1 1
Concussion 1 1
Spinal Column Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AliMed Corporation II Jan-22-2009
2 EOS Imaging II Jun-23-2017
3 Handicare USA, Inc. II Oct-24-2016
4 Handicare USA, Inc. II May-14-2015
5 Medline Industries Inc II Oct-05-2020
6 Medline Industries Inc II Nov-21-2017
7 North Coast Medical Inc II Apr-16-2012
8 Nutech Manufacturing Corp II Dec-01-2009
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