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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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 427 427
Leak/Splash 201 201
Use of Device Problem 161 161
Improper or Incorrect Procedure or Method 128 128
Burst Container or Vessel 123 123
Insufficient Information 98 98
Patient-Device Incompatibility 89 89
Break 82 82
Excessive Heating 72 72
Overheating of Device 70 70
Nonstandard Device 55 55
Unintended Ejection 40 40
Fluid/Blood Leak 40 40
Material Rupture 35 35
Temperature Problem 35 35
Defective Device 33 33
Appropriate Term/Code Not Available 30 30
Explosion 28 28
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 10 10
Material Split, Cut or Torn 10 10
Physical Resistance/Sticking 9 9
Therapeutic or Diagnostic Output Failure 9 9
Off-Label Use 9 9
Material Puncture/Hole 8 8
Unsealed Device Packaging 7 7
Difficult to Remove 7 7
Device Markings/Labelling Problem 7 7
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
Patient Device Interaction Problem 3 3
Activation Problem 2 2
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
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
Material Fragmentation 1 1
Material Frayed 1 1
Fire 1 1
Short Fill 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Peeled/Delaminated 1 1
Premature Activation 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 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 374 375
Burn, Thermal 329 332
No Known Impact Or Consequence To Patient 203 203
Pain 189 189
No Clinical Signs, Symptoms or Conditions 104 104
Swelling 97 97
Erythema 90 90
Chemical Exposure 88 88
Burn(s) 59 59
Itching Sensation 59 60
Burning Sensation 58 58
Scarring 51 52
Skin Irritation 46 46
Rash 44 44
Insufficient Information 38 38
Injury 35 35
Blister 34 34
Discomfort 33 33
Superficial (First Degree) Burn 32 32
Skin Discoloration 30 30
Full thickness (Third Degree) Burn 29 30
Hypersensitivity/Allergic reaction 20 20
Patient Problem/Medical Problem 19 19
No Consequences Or Impact To Patient 18 18
Skin Tears 17 17
Peeling 16 16
Tissue Damage 15 15
Irritation 14 14
Abrasion 14 14
No Code Available 14 14
Urticaria 13 13
Skin Inflammation 13 13
Scar Tissue 13 13
Hemorrhage/Bleeding 11 11
Skin Burning Sensation 10 10
No Information 10 10
Caustic/Chemical Burns 9 9
Tingling 9 9
Inflammation 8 8
Bruise/Contusion 8 8
Ulcer 8 8
Reaction 7 7
Tissue Breakdown 7 7
Red Eye(s) 7 7
Sleep Dysfunction 6 6
Skin Inflammation/ Irritation 6 6
Swelling/ Edema 5 5
Fluid Discharge 5 5
Impaired Healing 5 5
Contusion 5 5
Exposure to Body Fluids 5 5
Unspecified Infection 5 5
Eye Injury 5 5
Death 4 4
Rupture 4 4
Discharge 4 4
Complaint, Ill-Defined 4 4
Blood Loss 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Skin Infection 3 3
Cramp(s) 3 3
Skin Erosion 3 3
Necrosis 3 3
Abdominal Pain 3 3
Fall 3 3
Purulent Discharge 3 3
Dyspnea 2 2
Foreign Body Sensation in Eye 2 2
Abscess 2 2
Rheumatoid Arthritis 2 2
Nausea 2 2
Muscle Spasm(s) 2 2
Neuropathy 2 2
Increased Sensitivity 2 2
Therapeutic Effects, Unexpected 2 2
No Patient Involvement 2 2
Alteration In Body Temperature 2 2
Disability 2 2
Sweating 2 2
Numbness 2 2
Collapse 1 1
Neck Stiffness 1 1
Post Operative Wound Infection 1 1
Inadequate Pain Relief 1 1
Depression 1 1
Pressure Sores 1 1
Vascular System (Circulation), Impaired 1 1
Eye Burn 1 1
Ambulation Difficulties 1 1
Dysuria 1 1
Contact Dermatitis 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 1
Eye Pain 1 1
Device Embedded In Tissue or Plaque 1 1
Chills 1 1
Dizziness 1 1
Incomplete Induced Abortion 1 1
Tachycardia 1 1
Blurred Vision 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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