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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
CIRC MEDTECH
  SUBSTANTIALLY EQUIVALENT 1
MEDICFIT TECHNOLOGY SDN BHD
  SUBSTANTIALLY EQUIVALENT 1
MEDICON, E.G.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
NOVADIEN HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
WEE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WUHU SNNA MEDICAL TREATMENT APPLIANCE TECHNOLOGY C
  SUBSTANTIALLY EQUIVALENT 1
WUHU SNNDA MEDICAL TREATMENT APPLIANCE TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 20 20
2015 21 21
2016 147 147
2017 24 24
2018 13 13
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
Device Handling Problem 103 103
Insufficient Information 51 51
Device Dislodged or Dislocated 49 49
Adverse Event Without Identified Device or Use Problem 34 34
Device Operates Differently Than Expected 28 28
Use of Device Problem 25 25
Improper or Incorrect Procedure or Method 20 20
Appropriate Term/Code Not Available 12 12
Difficult to Open or Close 7 7
Pressure Problem 6 6
Defective Device 6 6
Break 5 5
Loose or Intermittent Connection 5 5
Off-Label Use 4 4
Contamination 4 4
Detachment of Device or Device Component 4 4
Device Slipped 4 4
Defective Component 3 3
Device Issue 3 3
Device Contamination With Biological Material 3 3
Positioning Failure 3 3
Material Integrity Problem 3 3
Mechanics Altered 3 3
Sharp Edges 3 3
Separation Problem 2 2
Scratched Material 2 2
Unintended Movement 2 2
No Apparent Adverse Event 2 2
Failure to Cut 2 2
Device-Device Incompatibility 2 2
Device Contamination with Chemical or Other Material 2 2
Material Discolored 2 2
Detachment Of Device Component 2 2
Material Fragmentation 2 2
Mechanical Problem 2 2
Inadequacy of Device Shape and/or Size 2 2
Failure to Obtain Sample 2 2
Problem with Sterilization 2 2
Fitting Problem 2 2
Structural Problem 1 1
Failure to Align 1 1
Failure to Form Staple 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Loss of or Failure to Bond 1 1
Misassembled 1 1
Difficult to Remove 1 1
Self-Activation or Keying 1 1
Material Separation 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Component Falling 1 1
Fail-Safe Design Failure 1 1
Human Factors Issue 1 1
Inadequate User Interface 1 1
Incorrect Device Or Component Shipped 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Unexpected Color 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Edema 113 113
Hemorrhage/Bleeding 45 45
Injury 28 28
No Known Impact Or Consequence To Patient 22 22
Patient Problem/Medical Problem 20 20
No Code Available 18 18
Laceration(s) 15 15
Blood Loss 13 13
Genital Bleeding 12 12
No Clinical Signs, Symptoms or Conditions 10 10
Tissue Damage 8 8
No Consequences Or Impact To Patient 7 7
Toxemia 7 8
Insufficient Information 7 7
No Information 4 4
Skin Tears 4 4
Unspecified Infection 3 3
Failure to Anastomose 2 2
Physical Entrapment 2 2
Death 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
No Patient Involvement 1 1
Foreign Body In Patient 1 1
Unspecified Tissue Injury 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Swelling 1 1
Post Traumatic Wound Infection 1 1
Wound Dehiscence 1 1
Abrasion 1 1
Adhesion(s) 1 1
Hematoma 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Jan-05-2017
2 Centurion Medical Products Corporation II Oct-10-2019
3 DeRoyal Industries Inc II Mar-04-2014
4 Deroyal Industries, Inc. Lafollette II Sep-16-2011
5 Instrumed International, Inc. II Dec-16-2014
6 MEDLINE INDUSTRIES, LP - Northfield II Sep-29-2023
7 MEDLINE INDUSTRIES, LP - Northfield II Apr-19-2023
8 Surgical Design Inc II May-06-2011
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