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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
2019 29 31
2020 7 7
2021 14 14
2022 10 10
2023 12 12
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 30 30
Fluid/Blood Leak 15 17
Patient Device Interaction Problem 6 6
Patient-Device Incompatibility 4 4
Excessive Heating 4 4
Temperature Problem 3 3
Device Contamination with Chemical or Other Material 3 3
Electrical /Electronic Property Problem 2 2
Leak/Splash 2 2
Overheating of Device 2 2
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Microbial Contamination of Device 1 1
Defective Device 1 1
Sparking 1 1
Device Markings/Labelling Problem 1 1
No Apparent Adverse Event 1 1
Appropriate Term/Code Not Available 1 1
Unintended Compatibility 1 1
Missing Information 1 1
Failure to Seal 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 14 14
No Clinical Signs, Symptoms or Conditions 9 9
Partial thickness (Second Degree) Burn 7 7
No Known Impact Or Consequence To Patient 6 6
Pain 5 5
Necrosis 4 4
No Consequences Or Impact To Patient 4 6
Full thickness (Third Degree) Burn 3 3
Superficial (First Degree) Burn 3 3
Hypersensitivity/Allergic reaction 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
Blister 2 2
Unspecified Tissue Injury 2 2
Unspecified Infection 2 2
Skin Discoloration 2 2
Skin Irritation 2 2
Bacterial Infection 2 2
Disability 2 2
Injury 2 2
Burn, Thermal 2 2
Electric Shock 2 2
No Patient Involvement 2 2
Tissue Breakdown 2 2
Deformity/ Disfigurement 1 1
Urticaria 1 1
Pressure Sores 1 1
Inadequate Pain Relief 1 1
No Code Available 1 1
Multiple Organ Failure 1 1
Swelling 1 1
Nerve Damage 1 1
Paralysis 1 1
Rash 1 1
Local Reaction 1 1
Scarring 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Cellulitis 1 1
Erythema 1 1
Fall 1 1
Fever 1 1
Hyperemia 1 1
Skin Burning Sensation 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
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