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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pack, hot or cold, disposable
Product CodeIMD
Regulation Number 890.5710
Device Class 1


Premarket Reviews
ManufacturerDecision
DENOVO PROUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
RAPID AID CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 33 33
2015 193 193
2016 213 213
2017 234 234
2018 262 262
2019 632 632
2020 248 248
2021 142 142
2022 202 202
2023 184 184
2024 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 662 662
Insufficient Information 351 351
Use of Device Problem 259 259
Improper or Incorrect Procedure or Method 258 258
Leak/Splash 220 220
Burst Container or Vessel 213 213
Overheating of Device 106 106
Patient-Device Incompatibility 102 102
Break 89 89
Excessive Heating 85 85
Temperature Problem 83 83
Device Operates Differently Than Expected 66 66
Nonstandard Device 55 55
Fluid/Blood Leak 47 47
Appropriate Term/Code Not Available 42 42
Unintended Ejection 40 40
Defective Device 39 39
Material Rupture 38 38
Product Quality Problem 34 34
Insufficient Heating 34 34
Explosion 29 29
Loss of or Failure to Bond 21 21
Material Deformation 18 18
Therapeutic or Diagnostic Output Failure 16 16
Material Protrusion/Extrusion 13 13
Material Integrity Problem 12 12
Unexpected Therapeutic Results 12 12
Off-Label Use 10 10
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 9 9
Material Puncture/Hole 9 9
Difficult to Remove 9 9
Device Markings/Labelling Problem 8 8
Unsealed Device Packaging 7 7
Failure To Adhere Or Bond 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Patient Device Interaction Problem 6 6
Packaging Problem 5 5
Material Separation 5 5
Device Slipped 5 5
Defective Component 5 5
Component Missing 5 5
Expiration Date Error 5 5
Device Issue 4 4
Chemical Spillage 4 4
Gel Leak 4 4
Device Emits Odor 4 4
Human-Device Interface Problem 4 4
Activation Problem 4 4
Output Problem 3 3
Device Handling Problem 3 3
Inadequate User Interface 3 3
Moisture Damage 3 3
Loose or Intermittent Connection 3 3
Device Expiration Issue 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged Prior to Use 3 3
Inadequacy of Device Shape and/or Size 3 3
Self-Activation or Keying 3 3
Fitting Problem 2 2
Incomplete or Missing Packaging 2 2
Detachment of Device or Device Component 2 2
Device Packaging Compromised 2 2
Device Dislodged or Dislocated 2 2
Tear, Rip or Hole in Device Packaging 2 2
Material Disintegration 2 2
Thermal Decomposition of Device 2 2
Melted 2 2
Labelling, Instructions for Use or Training Problem 2 2
Premature Activation 2 2
Difficult or Delayed Activation 2 2
Human Factors Issue 2 2
Material Twisted/Bent 2 2
Noise, Audible 2 2
Torn Material 2 2
Activation Failure 1 1
Difficult or Delayed Separation 1 1
Missing Information 1 1
No Pressure 1 1
Physical Property Issue 1 1
Protective Measures Problem 1 1
Scratched Material 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1
Peeled/Delaminated 1 1
Occlusion Within Device 1 1
Migration or Expulsion of Device 1 1
Charred 1 1
Crack 1 1
Material Discolored 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Fail-Safe Design Failure 1 1
Fire 1 1
Structural Problem 1 1
Split 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Expulsion 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 806 807
Burn, Thermal 500 503
Pain 354 354
No Known Impact Or Consequence To Patient 218 218
Erythema 168 168
No Clinical Signs, Symptoms or Conditions 165 165
Burn(s) 159 159
Swelling 156 156
Chemical Exposure 111 111
Itching Sensation 94 95
Burning Sensation 92 92
Scarring 81 82
Full thickness (Third Degree) Burn 70 71
Superficial (First Degree) Burn 70 70
Rash 69 69
Skin Irritation 61 61
Injury 55 55
Discomfort 54 54
Skin Discoloration 51 51
Insufficient Information 48 48
Blister 42 42
Scar Tissue 37 37
Tissue Damage 36 37
Hemorrhage/Bleeding 29 29
No Consequences Or Impact To Patient 29 29
Peeling 28 28
Patient Problem/Medical Problem 25 25
Skin Tears 25 25
Caustic/Chemical Burns 22 22
No Code Available 22 22
Hypersensitivity/Allergic reaction 22 22
Fluid Discharge 21 21
Purulent Discharge 19 19
Unspecified Infection 18 18
Rupture 18 18
Urticaria 18 18
Sleep Dysfunction 17 17
Skin Inflammation 16 16
No Information 16 16
Ulcer 16 16
Irritation 16 16
Inflammation 15 15
Abrasion 14 14
Skin Burning Sensation 12 12
Skin Inflammation/ Irritation 12 12
Reaction 10 10
Tingling 10 10
Tissue Breakdown 10 10
Discharge 9 9
Complaint, Ill-Defined 9 9
Bruise/Contusion 9 9
Eye Injury 9 9
Red Eye(s) 9 9
Skin Erosion 8 8
Contusion 8 8
Abdominal Pain 7 7
Exposure to Body Fluids 6 6
Impaired Healing 6 6
Inadequate Pain Relief 6 6
Sweating 6 6
Cramp(s) 5 5
Dyspnea 5 5
Nerve Damage 5 5
Nausea 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Skin Infection 5 5
Swelling/ Edema 5 5
High Blood Pressure/ Hypertension 4 4
Emotional Changes 4 4
Death 4 4
Fall 4 4
Chest Pain 4 4
Blurred Vision 4 4
Disability 3 3
Numbness 3 3
Alteration In Body Temperature 3 3
Blood Loss 3 3
No Patient Involvement 3 3
Fever 3 3
Foreign Body Sensation in Eye 3 3
Headache 3 3
Necrosis 3 3
Local Reaction 3 3
Increased Sensitivity 3 3
Tachycardia 2 2
Therapeutic Effects, Unexpected 2 2
Muscle Spasm(s) 2 2
Neuropathy 2 2
Loss of Range of Motion 2 2
Pyrosis/Heartburn 2 2
Hyperglycemia 2 2
Erosion 2 2
Rheumatoid Arthritis 2 2
Bacterial Infection 2 2
Abscess 2 2
Eye Pain 2 2
Ambulation Difficulties 2 2
Eye Burn 2 2
Neck Stiffness 2 2
Pressure Sores 2 2

Recalls
Manufacturer Recall Class Date Posted
1 CooperSurgical, Inc. II Aug-24-2019
2 CooperSurgical, Inc. II Apr-07-2015
3 CooperSurgical, Inc. II Mar-19-2015
4 PF Consumer Healthcare 1 LLC II May-28-2019
5 Pfizer Global II Dec-16-2010
6 Pfizer Inc. II Dec-05-2018
7 Philips Electronics North America Corporation II Apr-04-2016
8 Philips Electronics North America Corporation II Dec-24-2015
9 Philips North America Llc II Jan-19-2022
10 Philips North America Llc II Jan-18-2022
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