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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
ELBIO CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PAIN MANAGEMENT TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 49 49
2015 60 60
2016 44 44
2017 43 43
2018 40 40
2019 29 31
2020 7 7
2021 14 14
2022 10 10
2023 12 12
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 55 55
Fluid/Blood Leak 44 46
Leak/Splash 39 39
Break 35 35
Scratched Material 32 32
Insufficient Information 28 28
Device Operates Differently Than Expected 20 20
Crack 11 11
Improper or Incorrect Procedure or Method 9 9
Overheating of Device 7 7
Hole In Material 7 7
Patient Device Interaction Problem 6 6
Temperature Problem 4 4
Excessive Heating 4 4
Patient-Device Incompatibility 4 4
Sparking 3 3
Inappropriate/Inadequate Shock/Stimulation 3 3
Moisture Damage 3 3
Nonstandard Device 3 3
Electrical /Electronic Property Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Improper Flow or Infusion 3 3
Material Protrusion/Extrusion 3 3
Appropriate Term/Code Not Available 2 2
Fire 2 2
Mechanical Problem 2 2
Material Separation 2 2
Component Missing 2 2
Defective Device 2 2
Device Displays Incorrect Message 2 2
Difficult or Delayed Activation 1 1
Application Program Problem 1 1
Device Markings/Labelling Problem 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Rupture 1 1
Insufficient Flow or Under Infusion 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Inflation Problem 1 1
Fracture 1 1
Grounding Malfunction 1 1
Device Alarm System 1 1
Fail-Safe Design Failure 1 1
Deflation Problem 1 1
Burst Container or Vessel 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Unintended Compatibility 1 1
Missing Information 1 1
Failure to Seal 1 1
Infusion or Flow Problem 1 1
Electrical Shorting 1 1
Electronic Property Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 128 128
Burn(s) 34 34
No Consequences Or Impact To Patient 27 29
Partial thickness (Second Degree) Burn 19 20
Swelling 16 16
Erythema 15 15
Burn, Thermal 11 11
No Information 10 10
Pain 10 10
No Clinical Signs, Symptoms or Conditions 9 9
Full thickness (Third Degree) Burn 9 9
Necrosis 8 8
Skin Discoloration 6 6
Injury 6 6
Electric Shock 5 5
Superficial (First Degree) Burn 4 4
Tissue Damage 4 4
Skin Irritation 3 3
Rash 3 3
Hypersensitivity/Allergic reaction 3 3
Fever 3 3
No Patient Involvement 3 3
Tissue Breakdown 3 3
Numbness 3 3
Disability 3 3
No Code Available 3 3
Muscle/Tendon Damage 3 3
Swelling/ Edema 3 3
Insufficient Information 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bacterial Infection 2 2
Unspecified Tissue Injury 2 2
Blister 2 2
Impaired Healing 2 2
Shock from Patient Lead(s) 2 2
Unspecified Infection 2 2
Fall 2 2
Thrombosis 2 2
Burning Sensation 1 1
Tingling 1 1
Stenosis 1 1
Urticaria 1 1
Pressure Sores 1 1
Discomfort 1 1
Local Reaction 1 1
Staphylococcus Aureus 1 1
Scarring 1 1
Shock 1 1
Paralysis 1 1
Necrosis Of Flap Tissue 1 1
Nerve Damage 1 1
Irritation 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Headache 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hyperemia 1 1
Cellulitis 1 1
Chest Pain 1 1
Dyspnea 1 1
Ecchymosis 1 1
Patient Problem/Medical Problem 1 1
Inadequate Pain Relief 1 1
Deformity/ Disfigurement 1 1
Loss of consciousness 1 1
Vascular System (Circulation), Impaired 1 1
Skin Burning Sensation 1 1
Multiple Organ Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Breg Inc II Feb-12-2013
2 Breg Inc, An Orthofix Company II Sep-04-2009
3 Cincinnati Sub-Zero Products Inc II Feb-19-2015
4 Cincinnati Sub-Zero Products Inc II Feb-04-2010
5 Cincinnati Sub-Zero Products LLC, a Gentherm Company III Aug-19-2019
6 DeRoyal Industries Inc II Jan-27-2014
7 Gentherm Medical, LLC II Jan-13-2022
8 Pro Trainers' Choice Company II Jun-24-2011
9 Stryker Medical Division of Stryker Corporation III Mar-14-2018
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