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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 pack, hot or cold, disposable
Product CodeIMD
Regulation Number 890.5710
Device Class 1


Premarket Reviews
ManufacturerDecision
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 262 262
2019 632 632
2020 248 248
2021 142 142
2022 202 202
2023 153 153

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 443 443
Leak/Splash 202 202
Burst Container or Vessel 180 180
Use of Device Problem 166 166
Insufficient Information 161 161
Improper or Incorrect Procedure or Method 135 135
Patient-Device Incompatibility 89 89
Break 83 83
Excessive Heating 78 78
Overheating of Device 70 70
Nonstandard Device 55 55
Fluid/Blood Leak 41 41
Unintended Ejection 40 40
Material Rupture 35 35
Temperature Problem 35 35
Defective Device 34 34
Appropriate Term/Code Not Available 32 32
Explosion 29 29
Insufficient Heating 25 25
Loss of or Failure to Bond 20 20
Material Deformation 17 17
Product Quality Problem 16 16
Material Protrusion/Extrusion 12 12
Material Integrity Problem 11 11
Off-Label Use 10 10
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 9 9
Therapeutic or Diagnostic Output Failure 9 9
Material Puncture/Hole 9 9
Unsealed Device Packaging 7 7
Difficult to Remove 7 7
Device Markings/Labelling Problem 7 7
Patient Device Interaction Problem 6 6
Device Operates Differently Than Expected 5 5
Expiration Date Error 5 5
Unexpected Therapeutic Results 5 5
Defective Component 4 4
Component Missing 4 4
Packaging Problem 4 4
Gel Leak 4 4
Moisture Damage 3 3
Material Separation 3 3
Device Slipped 3 3
Device Emits Odor 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged Prior to Use 3 3
Output Problem 3 3
Activation Problem 3 3
Fitting Problem 2 2
Incomplete or Missing Packaging 2 2
Tear, Rip or Hole in Device Packaging 2 2
Detachment of Device or Device Component 2 2
Premature Activation 2 2
Inadequacy of Device Shape and/or Size 2 2
Melted 2 2
Labelling, Instructions for Use or Training Problem 2 2
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Crack 1 1
Material Discolored 1 1
Fire 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Short Fill 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Peeled/Delaminated 1 1
Material Twisted/Bent 1 1
Protective Measures Problem 1 1
No Pressure 1 1
Activation Failure 1 1
Noise, Audible 1 1
Structural Problem 1 1
Difficult or Delayed Activation 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Inadequate User Interface 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 407 408
Burn, Thermal 329 332
No Known Impact Or Consequence To Patient 203 203
Pain 200 200
No Clinical Signs, Symptoms or Conditions 150 150
Chemical Exposure 97 97
Swelling 97 97
Burn(s) 93 93
Erythema 92 92
Itching Sensation 62 63
Burning Sensation 59 59
Scarring 51 52
Rash 48 48
Insufficient Information 47 47
Skin Irritation 46 46
Superficial (First Degree) Burn 42 42
Blister 40 40
Injury 35 35
Discomfort 34 34
Skin Discoloration 32 32
Full thickness (Third Degree) Burn 31 32
Hypersensitivity/Allergic reaction 20 20
Patient Problem/Medical Problem 19 19
No Consequences Or Impact To Patient 18 18
Peeling 17 17
Skin Tears 17 17
Scar Tissue 15 15
Tissue Damage 15 15
Irritation 14 14
Abrasion 14 14
No Code Available 14 14
Urticaria 13 13
Skin Inflammation 13 13
Hemorrhage/Bleeding 12 12
Skin Burning Sensation 11 11
Skin Inflammation/ Irritation 10 10
No Information 10 10
Ulcer 10 10
Caustic/Chemical Burns 9 9
Tingling 9 9
Inflammation 8 8
Bruise/Contusion 8 8
Red Eye(s) 7 7
Tissue Breakdown 7 7
Reaction 7 7
Sleep Dysfunction 6 6
Eye Injury 6 6
Unspecified Infection 5 5
Contusion 5 5
Exposure to Body Fluids 5 5
Fluid Discharge 5 5
Impaired Healing 5 5
Swelling/ Edema 5 5
Skin Infection 4 4
Discharge 4 4
Complaint, Ill-Defined 4 4
Death 4 4
Purulent Discharge 4 4
Rupture 4 4
Cramp(s) 3 3
Skin Erosion 3 3
Necrosis 3 3
Fall 3 3
Foreign Body Sensation in Eye 3 3
Abdominal Pain 3 3
Blood Loss 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Eye Pain 2 2
No Patient Involvement 2 2
Alteration In Body Temperature 2 2
Eye Burn 2 2
Disability 2 2
Sweating 2 2
Numbness 2 2
Abscess 2 2
Rheumatoid Arthritis 2 2
Dyspnea 2 2
Emotional Changes 2 2
Nausea 2 2
Muscle Spasm(s) 2 2
Local Reaction 2 2
Neuropathy 2 2
Increased Sensitivity 2 2
Blurred Vision 2 2
Therapeutic Effects, Unexpected 2 2
Chills 1 1
Dizziness 1 1
Incomplete Induced Abortion 1 1
Visual Impairment 1 1
Loss of Vision 1 1
Vomiting 1 1
Tachycardia 1 1
Respiratory Distress 1 1
Myocardial Infarction 1 1
Nerve Damage 1 1
Loss of Range of Motion 1 1
Dry Eye(s) 1 1
Headache 1 1
Pyrosis/Heartburn 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Aug-24-2019
2 PF Consumer Healthcare 1 LLC II May-28-2019
3 Pfizer Inc. II Dec-05-2018
4 Philips North America Llc II Jan-19-2022
5 Philips North America Llc II Jan-18-2022
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