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TPLC
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show TPLC since
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Device
pack, hot or cold, water circulating
Product Code
ILO
Regulation Number
890.5720
Device Class
2
Premarket Reviews
Manufacturer
Decision
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
6
6
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
Device Contamination with Chemical or Other Material
3
3
Temperature Problem
3
3
Leak/Splash
2
2
Overheating of Device
2
2
Electrical /Electronic Property Problem
2
2
Sparking
1
1
Unintended Electrical Shock
1
1
Device Markings/Labelling Problem
1
1
Defective Device
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Microbial Contamination of Device
1
1
Unintended Compatibility
1
1
No Apparent Adverse Event
1
1
Missing Information
1
1
Appropriate Term/Code Not Available
1
1
Failure to Seal
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
No Consequences Or Impact To Patient
4
6
Necrosis
4
4
Superficial (First Degree) Burn
3
3
Full thickness (Third Degree) Burn
3
3
Hypersensitivity/Allergic reaction
3
3
Swelling/ Edema
3
3
Unspecified Tissue Injury
3
3
Muscle/Tendon Damage
3
3
Tissue Breakdown
2
2
Bacterial Infection
2
2
Insufficient Information
2
2
No Patient Involvement
2
2
Injury
2
2
Skin Discoloration
2
2
Blister
2
2
Burn, Thermal
2
2
Disability
2
2
Skin Irritation
2
2
Electric Shock
2
2
Unspecified Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Cellulitis
1
1
Multiple Organ Failure
1
1
Paralysis
1
1
Rash
1
1
Fever
1
1
Itching Sensation
1
1
Swelling
1
1
Nerve Damage
1
1
Local Reaction
1
1
Erythema
1
1
Scarring
1
1
Laceration(s)
1
1
Fall
1
1
No Code Available
1
1
Deformity/ Disfigurement
1
1
Pressure Sores
1
1
Inadequate Pain Relief
1
1
Urticaria
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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