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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, water circulating
Product CodeILO
Regulation Number 890.5720
Device Class 2


Premarket Reviews
ManufacturerDecision
PAIN MANAGEMENT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 43 43
2018 40 40
2019 29 31
2020 7 7
2021 14 14
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid Leak 35 37
Adverse Event Without Identified Device or Use Problem 33 33
Leak/Splash 16 16
Insufficient Information 8 8
Device Operates Differently Than Expected 6 6
Patient Device Interaction Problem 5 5
Patient-Device Incompatibility 4 4
Overheating of Device 4 4
Temperature Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Hole In Material 2 2
Excessive Heating 2 2
Material Separation 2 2
Improper or Incorrect Procedure or Method 2 2
Mechanical Problem 2 2
Break 2 2
Electrical /Electronic Property Problem 2 2
Device Alarm System 1 1
Burst Container or Vessel 1 1
Fracture 1 1
Microbial Contamination of Device 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Unintended Compatibility 1 1
Missing Information 1 1
Appropriate Term/Code Not Available 1 1
Application Program Problem 1 1
Device Markings/Labelling Problem 1 1
Electronic Property Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 47 47
No Consequences Or Impact To Patient 13 15
Partial thickness (Second Degree) Burn 11 11
Burn(s) 10 10
Burn, Thermal 8 8
No Information 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Necrosis 5 5
Pain 5 5
Superficial (First Degree) Burn 4 4
Swelling/ Edema 3 3
Full thickness (Third Degree) Burn 3 3
Injury 3 3
Skin Irritation 3 3
Swelling 2 2
Disability 2 2
Electric Shock 2 2
No Patient Involvement 2 2
Tissue Breakdown 2 2
Rash 2 2
Bacterial Infection 2 2
Skin Discoloration 2 2
Erythema 2 2
Hypersensitivity/Allergic reaction 2 2
Unspecified Infection 2 2
No Code Available 2 2
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Multiple Organ Failure 1 1
Muscle/Tendon Damage 1 1
Skin Burning Sensation 1 1
Unspecified Tissue Injury 1 1
Shock from Patient Lead(s) 1 1
Irritation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Hyperemia 1 1
Cellulitis 1 1
Local Reaction 1 1
Scarring 1 1
Paralysis 1 1
Nerve Damage 1 1
Inadequate Pain Relief 1 1
Deformity/ Disfigurement 1 1
Thrombosis 1 1
Burning Sensation 1 1
Urticaria 1 1
Pressure Sores 1 1
Discomfort 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cincinnati Sub-Zero Products LLC, a Gentherm Company III Aug-19-2019
2 Gentherm Medical, LLC II Jan-13-2022
3 Stryker Medical Division of Stryker Corporation III Mar-14-2018
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