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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device clamp, circumcision
Product CodeHFX
Regulation Number 884.4530
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
WEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 11 11
2020 22 22
2021 5 5
2022 3 3
2023 33 33
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Appropriate Term/Code Not Available 11 11
Insufficient Information 7 7
Pressure Problem 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Defective Device 5 5
Contamination 4 4
Off-Label Use 4 4
Positioning Failure 3 3
Detachment of Device or Device Component 3 3
Difficult to Open or Close 2 2
Break 2 2
Failure to Cut 2 2
Material Integrity Problem 2 2
Unintended Movement 2 2
Material Discolored 2 2
Material Fragmentation 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Problem with Sterilization 2 2
Defective Component 2 2
Sharp Edges 2 2
Separation Problem 2 2
Unexpected Color 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Obtain Sample 1 1
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Device Slipped 1 1
Excess Flow or Over-Infusion 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Contamination /Decontamination Problem 1 1
Device Dislodged or Dislocated 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 23 23
Genital Bleeding 12 12
Injury 10 10
No Clinical Signs, Symptoms or Conditions 10 10
No Known Impact Or Consequence To Patient 8 8
Insufficient Information 7 7
Laceration(s) 6 6
Skin Tears 4 4
Blood Loss 2 2
No Code Available 2 2
Tissue Damage 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Discomfort 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Adhesion(s) 1 1
Hematoma 1 1
Unspecified Tissue Injury 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Centurion Medical Products Corporation II Oct-10-2019
2 MEDLINE INDUSTRIES, LP - Northfield II Sep-29-2023
3 MEDLINE INDUSTRIES, LP - Northfield II Apr-19-2023
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