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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
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 381 381
Leak/Splash 179 179
Burst Container or Vessel 167 167
Insufficient Information 162 162
Use of Device Problem 135 135
Improper or Incorrect Procedure or Method 106 106
Break 78 78
Excessive Heating 77 77
Patient-Device Incompatibility 76 76
Overheating of Device 44 44
Unintended Ejection 40 40
Fluid/Blood Leak 33 33
Nonstandard Device 33 33
Material Rupture 33 33
Explosion 29 29
Defective Device 28 28
Appropriate Term/Code Not Available 27 27
Temperature Problem 25 25
Insufficient Heating 25 25
Loss of or Failure to Bond 18 18
Material Deformation 16 16
Material Protrusion/Extrusion 11 11
Product Quality Problem 11 11
Off-Label Use 10 10
Material Puncture/Hole 9 9
Material Integrity Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Material Split, Cut or Torn 8 8
Physical Resistance/Sticking 8 8
Device Markings/Labelling Problem 7 7
Difficult to Remove 7 7
Unsealed Device Packaging 6 6
Patient Device Interaction Problem 6 6
Unexpected Therapeutic Results 5 5
Expiration Date Error 4 4
Defective Component 4 4
Packaging Problem 4 4
Activation Problem 4 4
Output Problem 3 3
Component Missing 3 3
Device Damaged Prior to Use 3 3
Activation, Positioning or Separation Problem 3 3
Device Emits Odor 3 3
Gel Leak 3 3
Moisture Damage 3 3
Labelling, Instructions for Use or Training Problem 2 2
Premature Activation 2 2
Material Separation 2 2
Fitting Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Detachment of Device or Device Component 2 2
Incomplete or Missing Packaging 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Pressure 1 1
Material Twisted/Bent 1 1
Protective Measures Problem 1 1
Activation Failure 1 1
Noise, Audible 1 1
Tear, Rip or Hole in Device Packaging 1 1
Structural Problem 1 1
Connection Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1
Inadequate User Interface 1 1
Short Fill 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 Too Rigid or Stiff 1 1
Loose or Intermittent Connection 1 1
Melted 1 1
Crack 1 1
Material Discolored 1 1
Material Fragmentation 1 1
Material Frayed 1 1
Fire 1 1
Difficult or Delayed Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 294 294
Burn, Thermal 239 241
No Known Impact Or Consequence To Patient 189 189
Pain 166 166
No Clinical Signs, Symptoms or Conditions 165 165
Burn(s) 113 113
Chemical Exposure 83 83
Erythema 77 77
Swelling 68 68
Burning Sensation 52 52
Itching Sensation 50 50
Insufficient Information 48 48
Superficial (First Degree) Burn 46 46
Rash 43 43
Blister 42 42
Skin Irritation 37 37
Discomfort 30 30
Scarring 28 28
Skin Discoloration 27 27
Injury 27 27
Full thickness (Third Degree) Burn 21 21
Hypersensitivity/Allergic reaction 20 20
No Consequences Or Impact To Patient 18 18
Peeling 18 18
Skin Tears 16 16
Ulcer 14 14
Scar Tissue 14 14
Abrasion 13 13
Urticaria 13 13
No Code Available 13 13
Skin Burning Sensation 12 12
Skin Inflammation/ Irritation 12 12
Patient Problem/Medical Problem 12 12
Irritation 12 12
Tissue Damage 11 11
Skin Inflammation 10 10
Hemorrhage/Bleeding 9 9
Caustic/Chemical Burns 8 8
Tissue Breakdown 7 7
Reaction 7 7
Inflammation 7 7
Red Eye(s) 7 7
Tingling 6 6
Bruise/Contusion 6 6
No Information 6 6
Skin Infection 5 5
Swelling/ Edema 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Sleep Dysfunction 5 5
Contusion 5 5
Unspecified Infection 5 5
Dyspnea 4 4
Death 4 4
Purulent Discharge 4 4
Exposure to Body Fluids 4 4
Chest Pain 3 3
Eye Injury 3 3
Foreign Body Sensation in Eye 3 3
Rupture 3 3
Skin Erosion 3 3
Complaint, Ill-Defined 3 3
Impaired Healing 3 3
Blood Loss 3 3
No Patient Involvement 2 2
Discharge 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 2 2
Eye Burn 2 2
Sweating 2 2
Numbness 2 2
Eye Pain 2 2
Localized Skin Lesion 2 2
Blurred Vision 2 2
Cramp(s) 2 2
Therapeutic Effects, Unexpected 2 2
Local Reaction 2 2
Increased Sensitivity 2 2
Necrosis 2 2
Muscle Spasm(s) 2 2
Fall 2 2
Emotional Changes 2 2
Abdominal Pain 2 2
Abscess 2 2
Adhesion(s) 1 1
Arrhythmia 1 1
Rheumatoid Arthritis 1 1
Cellulitis 1 1
Corneal Abrasion 1 1
Dry Eye(s) 1 1
Dehydration 1 1
Gastritis 1 1
Headache 1 1
Pyrosis/Heartburn 1 1
Hyperglycemia 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Myocardial Infarction 1 1
Nausea 1 1
Neuropathy 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 Philips North America Llc II Jan-19-2022
4 Philips North America Llc II Jan-18-2022
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