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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
2018 13 13
2019 11 11
2020 22 22
2021 5 5
2022 3 3
2023 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 10 10
Defective Device 5 5
Adverse Event Without Identified Device or Use Problem 5 5
Pressure Problem 5 5
Contamination 4 4
Off-Label Use 4 4
Positioning Failure 3 3
Break 3 3
Detachment of Device or Device Component 3 3
Appropriate Term/Code Not Available 3 3
Sharp Edges 2 2
Separation Problem 2 2
Unintended Movement 2 2
Failure to Obtain Sample 2 2
Failure to Cut 2 2
Device Contamination with Chemical or Other Material 2 2
Material Integrity Problem 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Material Discolored 2 2
Material Fragmentation 2 2
Defective Component 2 2
Problem with Sterilization 2 2
Use of Device Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Structural Problem 1 1
Failure to Align 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Slipped 1 1
Excess Flow or Over-Infusion 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Mechanics Altered 1 1
Contamination /Decontamination Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Loss of or Failure to Bond 1 1
Failure to Form Staple 1 1
Device Operates Differently Than Expected 1 1
Device-Device Incompatibility 1 1
Difficult to Open or Close 1 1
Device Dislodged or Dislocated 1 1
Unexpected Color 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hemorrhage/Bleeding 16 16
Injury 14 14
No Known Impact Or Consequence To Patient 10 10
Genital Bleeding 9 9
No Clinical Signs, Symptoms or Conditions 9 9
Insufficient Information 7 7
Laceration(s) 7 7
Blood Loss 4 4
No Code Available 3 3
Tissue Damage 3 3
No Consequences Or Impact To Patient 1 1
Discomfort 1 1
Foreign Body In Patient 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Swelling/ Edema 1 1
Abrasion 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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