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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device adaptor, hygiene
Product CodeILS
Regulation Number 890.5050
Device Class 1

MDR Year MDR Reports MDR Events
2014 705 705
2015 702 702
2016 411 411
2017 48 48
2018 36 36
2019 50 50
2020 32 32
2021 27 27
2022 45 45
2023 59 59
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Crack 755 755
Break 446 446
Bent 215 215
Unstable 142 142
Collapse 81 81
Out-Of-Box Failure 68 68
Device Operates Differently Than Expected 58 58
Detachment Of Device Component 44 44
Material Integrity Problem 42 42
Product Quality Problem 40 40
Adverse Event Without Identified Device or Use Problem 39 39
Component Missing 33 33
Device Slipped 31 31
Fracture 29 29
Split 24 24
Material Twisted/Bent 24 24
Loose or Intermittent Connection 22 22
Mechanical Problem 20 20
Insufficient Information 19 19
Component Falling 18 18
Detachment of Device or Device Component 17 17
Deformation Due to Compressive Stress 17 17
Unintended Movement 17 17
Material Fragmentation 12 12
Corroded 11 11
Mechanics Altered 11 11
Device Dislodged or Dislocated 10 10
Material Separation 10 10
Material Deformation 10 10
Torn Material 10 10
Connection Problem 8 8
Mechanical Jam 8 8
Unraveled Material 8 8
Structural Problem 7 7
Sticking 7 7
Device Inoperable 7 7
Use of Device Problem 7 7
Appropriate Term/Code Not Available 7 7
Scratched Material 6 6
Improper or Incorrect Procedure or Method 6 6
Degraded 6 6
Device Damaged Prior to Use 5 5
Defective Component 5 5
Defective Device 4 4
Device Tipped Over 4 4
Leak/Splash 4 4
Misassembly by Users 4 4
Hole In Material 3 3
Naturally Worn 3 3
Positioning Problem 3 3
Material Protrusion/Extrusion 2 2
Device Contamination with Chemical or Other Material 2 2
Human-Device Interface Problem 2 2
Installation-Related Problem 2 2
Malposition of Device 2 2
Calibration Problem 2 2
Failure to Align 2 2
Fluid/Blood Leak 2 2
Bolus mechanism failure 2 2
Burst Container or Vessel 2 2
Material Too Rigid or Stiff 2 2
Fitting Problem 2 2
Temperature Problem 2 2
Noise, Audible 2 2
Patient Device Interaction Problem 2 2
Sharp Edges 2 2
No Apparent Adverse Event 1 1
Missing Value Reason 1 1
Inadequate Service 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Melted 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Material Frayed 1 1
Disconnection 1 1
Material Disintegration 1 1
Entrapment of Device 1 1
Flaked 1 1
Dent in Material 1 1
Difficult or Delayed Activation 1 1
Computer Operating System Problem 1 1
Incomplete or Missing Packaging 1 1
Solder Joint Fracture 1 1
Tear, Rip or Hole in Device Packaging 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure of Device to Self-Test 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 994 994
No Consequences Or Impact To Patient 465 465
Fall 273 273
Injury 81 81
No Information 70 70
Bruise/Contusion 62 62
Bone Fracture(s) 46 46
Laceration(s) 38 38
Pain 35 35
Head Injury 35 35
Complaint, Ill-Defined 29 29
Discomfort 26 26
No Code Available 24 24
No Patient Involvement 18 18
Skin Tears 15 15
Physical Entrapment 10 10
Concussion 10 10
Insufficient Information 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Hip Fracture 9 9
Abrasion 9 9
Swelling 9 9
Limb Fracture 7 7
Hemorrhage/Bleeding 6 6
Hematoma 5 5
Neck Pain 5 5
Fracture, Arm 4 4
Joint Dislocation 4 4
Sprain 4 4
Erythema 4 4
Swelling/ Edema 4 4
Vertebral Fracture 4 4
Muscle/Tendon Damage 3 3
Contusion 3 3
Tooth Fracture 3 3
Post Traumatic Wound Infection 2 2
Loss of consciousness 2 2
Unspecified Infection 2 2
Pressure Sores 2 2
Collapse 2 2
Death 2 2
Hemorrhage, Subdural 2 2
Muscular Rigidity 2 2
Damage to Ligament(s) 2 2
Loss of Range of Motion 2 2
Intervertebral Disc Compression or Protrusion 2 2
Easy Bruising 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Blister 1 1
Skin Infection 1 1
Skin Discoloration 1 1
Skin Irritation 1 1
Vertigo 1 1
Vomiting 1 1
Chills 1 1
Memory Loss/Impairment 1 1
Muscle Spasm(s) 1 1
Undesired Nerve Stimulation 1 1
Intracranial Hemorrhage 1 1
Hyperglycemia 1 1
Failure of Implant 1 1
Incontinence 1 1
Gangrene 1 1
Dyspnea 1 1
Edema 1 1
Emotional Changes 1 1
Burn(s) 1 1
Coma 1 1
Inadequate Pain Relief 1 1
Deformity/ Disfigurement 1 1
Ulcer 1 1
Cognitive Changes 1 1
Blood Loss 1 1
Needle Stick/Puncture 1 1
Suture Abrasion 1 1
Shaking/Tremors 1 1
Multiple Fractures 1 1
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Etac Supply Center Ab II Aug-13-2015
2 Etac Supply Center Ab II Jul-15-2015
3 Gf Health Products II Apr-05-2021
4 James Leckey Design Ltd II Apr-08-2020
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