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TPLC
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show TPLC since
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Device
pack, hot or cold, reusable
Regulation Description
Cold pack.
Product Code
IME
Regulation Number
890.5700
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
9
9
2021
6
6
2022
6
6
2023
5
5
2024
12
12
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
10
10
Burst Container or Vessel
2
2
Excessive Heating
2
2
Overheating of Device
2
2
Temperature Problem
2
2
Leak/Splash
1
1
Material Split, Cut or Torn
1
1
Fire
1
1
Material Puncture/Hole
1
1
Patient-Device Incompatibility
1
1
Insufficient Information
1
1
Use of Device Problem
1
1
Material Rupture
1
1
Device Handling Problem
1
1
Labelling, Instructions for Use or Training Problem
1
1
Material Separation
1
1
No Apparent Adverse Event
1
1
Explosion
1
1
Protective Measures Problem
1
1
Appropriate Term/Code Not Available
1
1
Unexpected Therapeutic Results
1
1
Human-Device Interface Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Burn(s)
13
13
Partial thickness (Second Degree) Burn
8
8
Erythema
4
4
Full thickness (Third Degree) Burn
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Blister
3
3
Skin Irritation
2
2
Swelling
2
2
Unspecified Tissue Injury
2
2
Unspecified Infection
1
1
Superficial (First Degree) Burn
1
1
Hypersensitivity/Allergic reaction
1
1
Red Eye(s)
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Necrosis
1
1
Inflammation
1
1
Itching Sensation
1
1
Burn, Thermal
1
1
Chemical Exposure
1
1
No Known Impact Or Consequence To Patient
1
1
Rash
1
1
Burning Sensation
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Pain
1
1
Scar Tissue
1
1
Visual Impairment
1
1
Anxiety
1
1
Caustic/Chemical Burns
1
1
Headache
1
1
Hemorrhage/Bleeding
1
1
Skin Burning Sensation
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
MEDLINE INDUSTRIES, LP - Northfield
II
Feb-09-2022
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