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TPLC
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Device
pack, hot or cold, water circulating
Regulation Description
Water circulating hot or cold pack.
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
2020
7
7
2021
14
14
2022
10
10
2023
12
12
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
23
23
Fluid/Blood Leak
10
10
Patient Device Interaction Problem
5
5
Excessive Heating
4
4
Device Contamination with Chemical or Other Material
2
2
Failure to Seal
1
1
Patient-Device Incompatibility
1
1
Temperature Problem
1
1
Leak/Splash
1
1
Electrical /Electronic Property Problem
1
1
Unintended Electrical Shock
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
13
13
No Clinical Signs, Symptoms or Conditions
11
11
Pain
4
4
Necrosis
3
3
Muscle/Tendon Damage
3
3
Unspecified Tissue Injury
3
3
Partial thickness (Second Degree) Burn
3
3
Swelling/ Edema
3
3
Tissue Breakdown
2
2
Hypersensitivity/Allergic reaction
2
2
Insufficient Information
2
2
Electric Shock
2
2
Unspecified Infection
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Blister
2
2
Full thickness (Third Degree) Burn
2
2
Disability
1
1
Rash
1
1
Fall
1
1
Itching Sensation
1
1
Bacterial Infection
1
1
Fever
1
1
Multiple Organ Failure
1
1
Nerve Damage
1
1
Inadequate Pain Relief
1
1
Skin Irritation
1
1
Skin Burning Sensation
1
1
Laceration(s)
1
1
Local Reaction
1
1
Skin Discoloration
1
1
No Code Available
1
1
Urticaria
1
1
Cellulitis
1
1
Erythema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Gentherm Medical, LLC
II
Jan-13-2022
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