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TPLC
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show TPLC since
2009
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2011
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2013
2014
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2019
2020
2021
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2023
2024
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Device
pack, hot or cold, reusable
Product Code
IME
Regulation Number
890.5700
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
11
11
2016
24
24
2017
15
15
2018
17
17
2019
11
11
2020
9
9
2021
6
6
2022
6
6
2023
5
5
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
32
32
Burst Container or Vessel
11
11
Leak/Splash
10
10
Fire
9
9
Overheating of Device
8
8
Use of Device Problem
8
8
Temperature Problem
6
6
Insufficient Information
5
5
Device Operates Differently Than Expected
4
4
Improper or Incorrect Procedure or Method
4
4
Patient-Device Incompatibility
4
4
Device Emits Odor
3
3
Melted
3
3
Thermal Decomposition of Device
3
3
Device Handling Problem
3
3
Explosion
2
2
Excessive Heating
2
2
Break
2
2
Material Separation
2
2
Defective Device
2
2
Physical Property Issue
2
2
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
Device Packaging Compromised
1
1
Excessive Cooling
1
1
Human Factors Issue
1
1
Human-Device Interface Problem
1
1
Moisture or Humidity Problem
1
1
Chemical Spillage
1
1
Nonstandard Device
1
1
Defective Component
1
1
Device Slipped
1
1
Unexpected Therapeutic Results
1
1
Device Inoperable
1
1
Device Difficult to Setup or Prepare
1
1
Product Quality Problem
1
1
Material Rupture
1
1
Charred
1
1
Fluid/Blood Leak
1
1
Hole In Material
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Split, Cut or Torn
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Partial thickness (Second Degree) Burn
27
27
Burn(s)
25
25
No Known Impact Or Consequence To Patient
14
14
Burn, Thermal
14
14
Full thickness (Third Degree) Burn
9
9
Pain
7
7
Erythema
5
5
No Consequences Or Impact To Patient
5
5
Superficial (First Degree) Burn
5
5
Burning Sensation
4
4
Swelling
3
3
Rash
3
3
Injury
3
3
No Information
3
3
Hypersensitivity/Allergic reaction
2
2
Itching Sensation
2
2
Blister
2
2
Skin Irritation
2
2
Scar Tissue
2
2
Complaint, Ill-Defined
2
2
Caustic/Chemical Burns
2
2
No Clinical Signs, Symptoms or Conditions
1
1
Skin Discoloration
1
1
Anxiety
1
1
Skin Burning Sensation
1
1
Abdominal Pain
1
1
Unspecified Tissue Injury
1
1
Visual Impairment
1
1
Red Eye(s)
1
1
Chemical Exposure
1
1
Numbness
1
1
Perforation
1
1
Insufficient Information
1
1
Nerve Damage
1
1
Scarring
1
1
Unspecified Infection
1
1
Headache
1
1
Discomfort
1
1
Gangrene
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Bruise/Contusion
1
1
Local Reaction
1
1
Joint Swelling
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cardinal Health 200, LLC
II
Nov-07-2022
2
KT Health, LLC
II
Apr-21-2020
3
Lansinoh Laboratories Inc
II
Feb-04-2013
4
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-09-2022
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