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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device scalp cooling system
Definition A scalp cooling system is intended to reduce or prevent the frequency and severity of alopecia during chemotherapy in which alopecia-inducing chemotherapeutic agents are used.
Product CodePMC
Regulation Number 878.4360
Device Class 2


Premarket Reviews
ManufacturerDecision
COOLER HEADS CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIGNITANA INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 8 8
2021 3 3
2022 4 4
2023 17 17
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 23 23
Improper or Incorrect Procedure or Method 4 4
Inadequate or Insufficient Training 3 3
Moisture or Humidity Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Product Quality Problem 1 1
Disconnection 1 1
Leak/Splash 1 1
Lack of Maintenance Documentation or Guidelines 1 1
Temperature Problem 1 1
Fluid/Blood Leak 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Burn(s) 22 22
Cryogenic Burn 6 6
No Clinical Signs, Symptoms or Conditions 4 4
Superficial (First Degree) Burn 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Not Applicable 1 1
No Code Available 1 1
Blood Loss 1 1
Blister 1 1
Burning Sensation 1 1
Erythema 1 1
Swelling 1 1
Insufficient Information 1 1
Limb Fracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dignitana, Inc. II Mar-24-2022
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