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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, reusable
Product CodeIME
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 6 6

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
Use of Device Problem 8 8
Overheating of Device 8 8
Temperature Problem 6 6
Insufficient Information 5 5
Device Operates Differently Than Expected 4 4
Patient-Device Incompatibility 4 4
Improper or Incorrect Procedure or Method 4 4
Device Handling Problem 3 3
Thermal Decomposition of Device 3 3
Device Emits Odor 3 3
Melted 3 3
Excessive Heating 2 2
Break 2 2
Explosion 2 2
Material Separation 2 2
Defective Device 2 2
Physical Property Issue 2 2
Human-Device Interface Problem 1 1
Unexpected Therapeutic Results 1 1
Nonstandard Device 1 1
Product Quality Problem 1 1
Device Inoperable 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Device Slipped 1 1
Labelling, Instructions for Use or Training Problem 1 1
Excessive Cooling 1 1
Moisture or Humidity Problem 1 1
Fluid/Blood Leak 1 1
Noise, Audible 1 1
Material Puncture/Hole 1 1
Human Factors Issue 1 1
Charred 1 1
Hole In Material 1 1
Chemical Spillage 1 1
Device Packaging Compromised 1 1
Device Difficult to Setup or Prepare 1 1
Defective Component 1 1
Material Rupture 1 1
Protective Measures Problem 1 1
Appropriate Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Partial thickness (Second Degree) Burn 27 27
Burn(s) 25 25
Burn, Thermal 14 14
No Known Impact Or Consequence To Patient 14 14
Full thickness (Third Degree) Burn 9 9
Pain 7 7
Superficial (First Degree) Burn 5 5
No Consequences Or Impact To Patient 5 5
Erythema 5 5
Burning Sensation 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
No Information 3 3
Rash 3 3
Injury 3 3
Swelling 3 3
Hypersensitivity/Allergic reaction 2 2
Complaint, Ill-Defined 2 2
Skin Irritation 2 2
Chemical Exposure 2 2
Itching Sensation 2 2
Caustic/Chemical Burns 2 2
Blister 2 2
Unspecified Tissue Injury 2 2
Scar Tissue 2 2
Skin Burning Sensation 1 1
Bruise/Contusion 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1
Anxiety 1 1
Gangrene 1 1
Visual Impairment 1 1
Insufficient Information 1 1
Numbness 1 1
Discomfort 1 1
Joint Swelling 1 1
Nerve Damage 1 1
Skin Discoloration 1 1
Local Reaction 1 1
Scarring 1 1
Perforation 1 1
Red Eye(s) 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Unspecified Infection 1 1
Abdominal Pain 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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