• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device pack, hot or cold, water circulating
Regulation Description Water circulating hot or cold pack.
Product CodeILO
Regulation Number 890.5720
Device Class 2


Premarket Reviews
ManufacturerDecision
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
-
-